Safety and Efficacy of ACU-D1 in the Treatment of Acne Rosacea
Study Details
Study Description
Brief Summary
The study evaluated the safety, tolerability, and efficacy of ACCU-D1 when applied twice daily for 12 weeks in adult participants with moderate to severe acne rosacea. Two-third of the participants received ACCU-D1 while one-third of the participants received vehicle control.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: ACU-D1 Ointment Twice-daily application of ACU-D1 ointment to the face for 12 weeks. |
Drug: ACCU-D1
ACCU-D1
|
Placebo Comparator: ACU-D1 Ointment Vehicle Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks. |
Drug: Vehicle
Placebo Comparator
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Total Lesion Count at Week 12 [Baseline, Week 12]
Total lesion count was the sum of counts of the following lesion types (face only): Papule - raised inflammatory lesions, <0.5 cm in diameter with no visible purulent material; Pustule - raised inflammatory lesions, <0.5 cm in diameter with visible purulent material; Nodule - any circumscribed, inflammatory mass ≥0.5 cm in diameter.
Secondary Outcome Measures
- Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12 [Baseline; Weeks 2, 4, 8, and 12]
The IGA score is an ordered categorical value ranging from 0 (clear) to 4 (severe). A lower score indicated improvement in the condition. Score 0 (clear): no papules or pustules, no nodules, none or barely perceptible erythema Score 1 (near clear): very few (≤3) papules and/or pustules, no nodules, very mild erythema Score 2 (mild): few papules and pustules present, no nodules, mild erythema Score 3 (moderate): several papules and pustules are the predominant features, ≤2 nodules may be present, moderate erythema Score 4 (severe): numerous papules and pustules, multiple nodules may be present, severe erythema
- Percentage of Participants Who Were Treatment Responders at Week 12 [Baseline, Week 12]
Treatment responders were defined as participants who have either (1) 2 ordinal or more reductions in the IGA score from baseline or (2) an IGA score of 0 or 1. The IGA score is an ordered categorical value ranging from 0 (clear) to 4 (severe). A lower score indicated improvement in the condition. Score 0 (clear): no papules or pustules, no nodules, none or barely perceptible erythema Score 1 (near clear): very few (≤3) papules and/or pustules, no nodules, very mild erythema Score 2 (mild): few papules and pustules present, no nodules, mild erythema Score 3 (moderate): several papules and pustules are the predominant features, ≤2 nodules may be present, moderate erythema Score 4 (severe): numerous papules and pustules, multiple nodules may be present, severe erythema
- Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12 [Baseline; Weeks 2, 4, 8, and 12]
Papule - raised inflammatory lesions, <0.5 cm in diameter with no visible purulent material
- Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12 [Baseline; Weeks 2, 4, 8, and 12]
Pustule - raised inflammatory lesions, <0.5 cm in diameter with visible purulent material
- Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12 [Baseline; Weeks 2, 4, 8, and 12]
Nodule - any circumscribed, inflammatory mass ≥0.5 cm in diameter
- Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12 [Baseline; Weeks 2, 4, 8, and 12]
Papules + pustules lesions were the sum of counts of papule (raised inflammatory lesions, <0.5 cm in diameter with no visible purulent material) and pustule (raised inflammatory lesions, <0.5 cm in diameter with visible purulent material) lesions.
- Number of Participants With Adverse Events [Baseline to Week 14]
Number of participants reporting any adverse event including local tolerability of signs and symptoms of irritation, clinical laboratory safety tests, and vital signs.
Other Outcome Measures
- Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12 [Week 12]
Erythema score was evaluated by the investigator on a 0 to 3 scale with a lower score indicating lesser severity. Score 0 (clear): no erythema present Score 1 (mild): slight erythema Score 2 (moderate): definite erythema Score 3 (severe): marked, fiery erythema
- Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 [Day 1 (Post-application) and Weeks 2, 4, 8, and 14]
Erythema score was evaluated by the investigator on a 0 to 3 scale with a lower score indicating lesser severity. Score 0 (clear): no erythema present Score 1 (mild): slight erythema Score 2 (moderate): definite erythema Score 3 (severe): marked, fiery erythema
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant is male or non-pregnant and non-lactating female at least 18 years of age
-
Participant has a clinical diagnosis of stable papulopustular rosacea (type-2)
-
Participant has a total of ≥10 and ≤40 inflammatory lesions (papules, pustules, and nodules) on the face
-
Participant has ≤2 nodules on the face
-
Participant has an investigator's global assessment (IGA) score of ≥3
-
If the participant is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control for the duration of the study
-
Participant is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of rosacea or which exposes the participant to an unacceptable risk by study participation
-
Participant is willing and able to follow all study instructions and to attend all study visits
-
Participant is able to comprehend and willing to sign an informed consent form
Exclusion Criteria:
-
Participant is pregnant, nursing, or planning to become pregnant during the duration of the study
-
Participant has used systemic glucocorticosteroids within 42 days prior to Visit 1 (inhaled and ocular glucocorticosteroids are permitted)
-
Participant has used systemic antibiotics within 28 days prior to Visit 1
-
Participant has used any topical glucocorticosteroids on the face within 28 days prior to Visit 1
-
Participant has used any prescription or over-the-counter product for the treatment of acne or rosacea within 14 days prior to Visit 1
-
Participant is currently using any therapy that, in the investigator's opinion, is a photosensitizer (for example, phenothiazines, amiodarone, quinine, thiazides, sulphonamides, quinolones, etc.)
-
Participant currently has any skin disease (for example, psoriasis, atopic dermatitis, eczema), or condition (for example, actinic keratosis, photo-damage, sunburn, excessive hair, open wounds) that, in the investigator's opinion, might impair evaluation of rosacea or which exposes the subject to an unacceptable risk by study participation
-
Participant currently has, on the face, or has had on the face, any of the following within the specified period prior to Visit 1 that, in the investigator's opinion, might impair evaluation of rosacea or which exposes the subject to an unacceptable risk by study participation:
-
A cutaneous malignancy; 180 days
-
Experienced a sunburn; 14 days
-
Participant has facial hair, that in the investigator's opinion, might impair evaluation of rosacea or proper study medication application
-
Participant has a history of sensitivity to any of the ingredients in the study medications
-
Participant has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | DS Research | Louisville | Kentucky | United States | 40421 |
2 | DermResearch | Austin | Texas | United States | 78759 |
Sponsors and Collaborators
- Accuitis, Inc.
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- ACU-D1
Study Results
Participant Flow
Recruitment Details | The study was conducted at two sites in the United States. |
---|---|
Pre-assignment Detail | Eligible participants will be assigned in a random manner to 1 of the 2 study medications in a 2:1 ratio (ACU-D1 ointment: ACU-D1 ointment vehicle). |
Arm/Group Title | ACU-D1 Ointment | ACU-D1 Ointment Vehicle |
---|---|---|
Arm/Group Description | Twice-daily application of ACU-D1 ointment to the face for 12 weeks. | Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks. |
Period Title: Overall Study | ||
STARTED | 27 | 13 |
COMPLETED | 26 | 12 |
NOT COMPLETED | 1 | 1 |
Baseline Characteristics
Arm/Group Title | ACU-D1 Ointment | ACU-D1 Ointment Vehicle | Total |
---|---|---|---|
Arm/Group Description | Twice-daily application of ACU-D1 ointment to the face for 12 weeks. | Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks. | Total of all reporting groups |
Overall Participants | 27 | 13 | 40 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
49.59
(11.537)
|
51.08
(12.473)
|
50.08
(11.708)
|
Sex: Female, Male (Count of Participants) | |||
Female |
23
85.2%
|
11
84.6%
|
34
85%
|
Male |
4
14.8%
|
2
15.4%
|
6
15%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
5
18.5%
|
0
0%
|
5
12.5%
|
Not Hispanic or Latino |
22
81.5%
|
13
100%
|
35
87.5%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
0
0%
|
0
0%
|
0
0%
|
White |
27
100%
|
13
100%
|
40
100%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Total lesion count (number of lesions) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [number of lesions] |
18.00
(9.413)
|
20.46
(9.777)
|
18.80
(9.479)
|
Erythema score based on local tolerability as assessed by the investigator (Count of Participants) | |||
Score 0 (clear) |
1
3.7%
|
1
7.7%
|
2
5%
|
Score 1 (mild) |
5
18.5%
|
4
30.8%
|
9
22.5%
|
Score 2 (moderate) |
16
59.3%
|
5
38.5%
|
21
52.5%
|
Score 3 (severe) |
5
18.5%
|
3
23.1%
|
8
20%
|
Outcome Measures
Title | Change From Baseline in Total Lesion Count at Week 12 |
---|---|
Description | Total lesion count was the sum of counts of the following lesion types (face only): Papule - raised inflammatory lesions, <0.5 cm in diameter with no visible purulent material; Pustule - raised inflammatory lesions, <0.5 cm in diameter with visible purulent material; Nodule - any circumscribed, inflammatory mass ≥0.5 cm in diameter. |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Number of participants included participants in the MITT population with available data at Week 12. |
Arm/Group Title | ACU-D1 Ointment | ACU-D1 Ointment Vehicle |
---|---|---|
Arm/Group Description | Twice-daily application of ACU-D1 ointment to the face for 12 weeks. | Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks. |
Measure Participants | 26 | 11 |
Least Squares Mean (Standard Error) [number of lesions] |
-10.2
(1.08)
|
-12.0
(1.62)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.366 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Difference of Least Squares (LS) Mean |
Estimated Value | 1.8 | |
Confidence Interval |
(2-Sided) 95% -2.162 to 5.727 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.95 |
|
Estimation Comments |
Title | Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12 |
---|---|
Description | The IGA score is an ordered categorical value ranging from 0 (clear) to 4 (severe). A lower score indicated improvement in the condition. Score 0 (clear): no papules or pustules, no nodules, none or barely perceptible erythema Score 1 (near clear): very few (≤3) papules and/or pustules, no nodules, very mild erythema Score 2 (mild): few papules and pustules present, no nodules, mild erythema Score 3 (moderate): several papules and pustules are the predominant features, ≤2 nodules may be present, moderate erythema Score 4 (severe): numerous papules and pustules, multiple nodules may be present, severe erythema |
Time Frame | Baseline; Weeks 2, 4, 8, and 12 |
Outcome Measure Data
Analysis Population Description |
---|
MITT population. Number of participants analyzed included participants with available data at specific timepoint. |
Arm/Group Title | ACU-D1 Ointment | ACU-D1 Ointment Vehicle |
---|---|---|
Arm/Group Description | Twice-daily application of ACU-D1 ointment to the face for 12 weeks. | Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks. |
Measure Participants | 27 | 13 |
Week 2 |
-23
(0.2561)
|
-29
(0.1653)
|
Week 4 |
-35
(0.2387)
|
-26
(0.2771)
|
Week 8 |
-31
(0.2538)
|
-29
(0.2233)
|
Week 12 |
-31
(0.2588)
|
-26
(0.3583)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | Percent change from baseline at Week 2 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.1099 |
Comments | ||
Method | Van Elteren test | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | Percent change from baseline at Week 4 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.1653 |
Comments | ||
Method | Van Elteren test | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | Percent change from baseline at Week 8 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.8437 |
Comments | ||
Method | Van Elteren test | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | Percent change from baseline at Week 12 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.4644 |
Comments | ||
Method | Van Elteren test | |
Comments |
Title | Percentage of Participants Who Were Treatment Responders at Week 12 |
---|---|
Description | Treatment responders were defined as participants who have either (1) 2 ordinal or more reductions in the IGA score from baseline or (2) an IGA score of 0 or 1. The IGA score is an ordered categorical value ranging from 0 (clear) to 4 (severe). A lower score indicated improvement in the condition. Score 0 (clear): no papules or pustules, no nodules, none or barely perceptible erythema Score 1 (near clear): very few (≤3) papules and/or pustules, no nodules, very mild erythema Score 2 (mild): few papules and pustules present, no nodules, mild erythema Score 3 (moderate): several papules and pustules are the predominant features, ≤2 nodules may be present, moderate erythema Score 4 (severe): numerous papules and pustules, multiple nodules may be present, severe erythema |
Time Frame | Baseline, Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
MITT population. Number of participants analyzed included participants with available IGA score at Week 12. |
Arm/Group Title | ACU-D1 Ointment | ACU-D1 Ointment Vehicle |
---|---|---|
Arm/Group Description | Twice-daily application of ACU-D1 ointment to the face for 12 weeks. | Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks. |
Measure Participants | 26 | 11 |
Number [percentage of participants] |
19.2
71.1%
|
18.2
140%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 1.0 |
Comments | ||
Method | Fisher Exact | |
Comments |
Title | Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12 |
---|---|
Description | Papule - raised inflammatory lesions, <0.5 cm in diameter with no visible purulent material |
Time Frame | Baseline; Weeks 2, 4, 8, and 12 |
Outcome Measure Data
Analysis Population Description |
---|
MITT population. Number of participants analyzed included participants with available data at specified visits. |
Arm/Group Title | ACU-D1 Ointment | ACU-D1 Ointment Vehicle |
---|---|---|
Arm/Group Description | Twice-daily application of ACU-D1 ointment to the face for 12 weeks. | Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks. |
Measure Participants | 27 | 13 |
Week 2 |
-6.6
(1.09)
|
-7.95
(1.57)
|
Week 4 |
-9.7
(0.97)
|
-8.22
(1.44)
|
Week 8 |
-8.1
(1.16)
|
-10.30
(1.71)
|
Week 12 |
-9.2
(1.01)
|
-10.98
(1.53)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | Change from baseline at Week 2 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.495 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Difference of LS Mean |
Estimated Value | 1.3 | |
Confidence Interval |
(2-Sided) 95% -2.571 to 5.211 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.91 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | Change from baseline at Week 4 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.399 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Difference of LS Mean |
Estimated Value | -1.5 | |
Confidence Interval |
(2-Sided) 95% -5.014 to 2.045 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.74 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | Change from baseline at Week 8 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.290 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Difference of LS Mean |
Estimated Value | 2.2 | |
Confidence Interval |
(2-Sided) 95% -1.965 to 6.407 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.07 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | Change from baseline at Week 12 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.343 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Difference of LS Mean |
Estimated Value | 1.8 | |
Confidence Interval |
(2-Sided) 95% -1.953 to 5.469 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.83 |
|
Estimation Comments |
Title | Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12 |
---|---|
Description | Pustule - raised inflammatory lesions, <0.5 cm in diameter with visible purulent material |
Time Frame | Baseline; Weeks 2, 4, 8, and 12 |
Outcome Measure Data
Analysis Population Description |
---|
MITT population. Number of participants analyzed included participants with available data at specified visits. |
Arm/Group Title | ACU-D1 Ointment | ACU-D1 Ointment Vehicle |
---|---|---|
Arm/Group Description | Twice-daily application of ACU-D1 ointment to the face for 12 weeks. | Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks. |
Measure Participants | 27 | 13 |
Week 2 |
-0.4
(0.43)
|
-0.98
(0.62)
|
Week 4 |
-1.2
(0.20)
|
-1.63
(0.30)
|
Week 8 |
-1.1
(0.25)
|
-1.29
(0.38)
|
Week 12 |
-1.0
(0.31)
|
-1.04
(0.48)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | Change from baseline at Week 2 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.407 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Difference of LS Mean |
Estimated Value | 0.6 | |
Confidence Interval |
(2-Sided) 95% -0.894 to 2.155 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.75 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | Change from baseline at Week 4 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.291 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Difference of LS Mean |
Estimated Value | 0.4 | |
Confidence Interval |
(2-Sided) 95% -0.342 to 1.109 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.36 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | Change from baseline at Week 8 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.734 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Difference of LS Mean |
Estimated Value | 0.2 | |
Confidence Interval |
(2-Sided) 95% -0.763 to 1.073 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.45 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | Change from baseline in pustule lesions at Week 12 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.952 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Difference of LS Mean |
Estimated Value | 0.0 | |
Confidence Interval |
(2-Sided) 95% -1.128 to 1.197 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.57 |
|
Estimation Comments |
Title | Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12 |
---|---|
Description | Nodule - any circumscribed, inflammatory mass ≥0.5 cm in diameter |
Time Frame | Baseline; Weeks 2, 4, 8, and 12 |
Outcome Measure Data
Analysis Population Description |
---|
MITT population. Number of participants analyzed included participants with available data at specified visits. |
Arm/Group Title | ACU-D1 Ointment | ACU-D1 Ointment Vehicle |
---|---|---|
Arm/Group Description | Twice-daily application of ACU-D1 ointment to the face for 12 weeks. | Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks. |
Measure Participants | 27 | 13 |
Week 2 |
0.0
(0.04)
|
0.02
(0.06)
|
Week 4 |
0.0
(0.04)
|
-0.05
(0.06)
|
Week 8 |
0.0
(0.04)
|
-0.05
(0.06)
|
Week 12 |
0.0
(0.04)
|
0.04
(0.06)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | Change from baseline at Week 2 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.313 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Difference of LS Mean |
Estimated Value | -0.1 | |
Confidence Interval |
(2-Sided) 95% -0.215 to 0.069 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | Change from baseline at Week 4 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.942 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Difference of LS Mean |
Estimated Value | 0.0 | |
Confidence Interval |
(2-Sided) 95% -0.141 to 0.152 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | Change from baseline in nodule lesions at Week 8 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.284 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Difference of LS Mean |
Estimated Value | 0.1 | |
Confidence Interval |
(2-Sided) 95% -0.067 to 0.226 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | Change from baseline at Week 12 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.542 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Difference of LS Mean |
Estimated Value | 0.0 | |
Confidence Interval |
(2-Sided) 95% -0.198 to 0.105 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.08 |
|
Estimation Comments |
Title | Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12 |
---|---|
Description | Papules + pustules lesions were the sum of counts of papule (raised inflammatory lesions, <0.5 cm in diameter with no visible purulent material) and pustule (raised inflammatory lesions, <0.5 cm in diameter with visible purulent material) lesions. |
Time Frame | Baseline; Weeks 2, 4, 8, and 12 |
Outcome Measure Data
Analysis Population Description |
---|
MITT population. Number of participants analyzed included participants with available data at specified visits. |
Arm/Group Title | ACU-D1 Ointment | ACU-D1 Ointment Vehicle |
---|---|---|
Arm/Group Description | Twice-daily application of ACU-D1 ointment to the face for 12 weeks. | Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks. |
Measure Participants | 27 | 13 |
Week 2 |
-7.0
(1.16)
|
-8.97
(1.67)
|
Week 4 |
-10.9
(1.06)
|
-9.90
(1.57)
|
Week 8 |
-9.2
(1.19)
|
-11.65
(1.75)
|
Week 12 |
-10.2
(1.08)
|
-12.03
(1.62)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | Change from baseline at Week 2 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.333 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Difference of LS Mean |
Estimated Value | 2.0 | |
Confidence Interval |
(2-Sided) 95% -2.135 to 6.139 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.04 |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | Change from baseline at Week 4 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.591 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Difference of LS Mean |
Estimated Value | -1.0 | |
Confidence Interval |
(2-Sided) 95% -4.882 to 2.822 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.90 |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | Change from baseline at Week 8 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.254 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Difference of LS Mean |
Estimated Value | 2.5 | |
Confidence Interval |
(2-Sided) 95% -1.840 to 6.758 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.12 |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | ACU-D1 Ointment, ACU-D1 Ointment Vehicle |
---|---|---|
Comments | Change from baseline at Week 12 | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.356 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Difference of LS Mean |
Estimated Value | 1.8 | |
Confidence Interval |
(2-Sided) 95% -2.131 to 5.779 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.95 |
|
Estimation Comments |
Title | Number of Participants With Adverse Events |
---|---|
Description | Number of participants reporting any adverse event including local tolerability of signs and symptoms of irritation, clinical laboratory safety tests, and vital signs. |
Time Frame | Baseline to Week 14 |
Outcome Measure Data
Analysis Population Description |
---|
Safety population included all randomized participants who received at least 1 dose of study medication. |
Arm/Group Title | ACU-D1 Ointment | ACU-D1 Ointment Vehicle |
---|---|---|
Arm/Group Description | Twice-daily application of ACU-D1 ointment to the face for 12 weeks. | Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks. |
Measure Participants | 27 | 13 |
Count of Participants [Participants] |
11
40.7%
|
4
30.8%
|
Title | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Week 12 |
---|---|
Description | Erythema score was evaluated by the investigator on a 0 to 3 scale with a lower score indicating lesser severity. Score 0 (clear): no erythema present Score 1 (mild): slight erythema Score 2 (moderate): definite erythema Score 3 (severe): marked, fiery erythema |
Time Frame | Week 12 |
Outcome Measure Data
Analysis Population Description |
---|
Safety population included all randomized participants who received at least 1 dose of study medication. Number of participants analyzed included participants with available data at specified timepoints. |
Arm/Group Title | ACU-D1 Ointment | ACU-D1 Ointment Vehicle |
---|---|---|
Arm/Group Description | Twice-daily application of ACU-D1 ointment to the face for 12 weeks. | Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks. |
Measure Participants | 26 | 11 |
Score 0 (clear) |
1
3.7%
|
1
7.7%
|
Score 1 (mild) |
14
51.9%
|
3
23.1%
|
Score 2 (moderate) |
9
33.3%
|
6
46.2%
|
Score 3 (severe) |
2
7.4%
|
1
7.7%
|
Title | Number of Participants With Erythema Score Based on Local Tolerability as Assessed by the Investigator at Day 1 (Post-application) and Weeks 2, 4, 8, and 14 |
---|---|
Description | Erythema score was evaluated by the investigator on a 0 to 3 scale with a lower score indicating lesser severity. Score 0 (clear): no erythema present Score 1 (mild): slight erythema Score 2 (moderate): definite erythema Score 3 (severe): marked, fiery erythema |
Time Frame | Day 1 (Post-application) and Weeks 2, 4, 8, and 14 |
Outcome Measure Data
Analysis Population Description |
---|
Safety population. Number of participants analyzed included participants with available data at specified timepoints. |
Arm/Group Title | ACU-D1 Ointment | ACU-D1 Ointment Vehicle |
---|---|---|
Arm/Group Description | Twice-daily application of ACU-D1 ointment to the face for 12 weeks. | Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks. |
Measure Participants | 27 | 13 |
Score 0 (clear) |
1
3.7%
|
1
7.7%
|
Score 1 (mild) |
9
33.3%
|
4
30.8%
|
Score 2 (moderate) |
12
44.4%
|
4
30.8%
|
Score 3 (severe) |
5
18.5%
|
4
30.8%
|
Score 0 (clear) |
0
0%
|
0
0%
|
Score 1 (mild) |
12
44.4%
|
7
53.8%
|
Score 2 (moderate) |
12
44.4%
|
4
30.8%
|
Score 3 (severe) |
3
11.1%
|
2
15.4%
|
Score 0 (clear) |
0
0%
|
0
0%
|
Score 1 (mild) |
13
48.1%
|
4
30.8%
|
Score 2 (moderate) |
12
44.4%
|
7
53.8%
|
Score 3 (severe) |
2
7.4%
|
1
7.7%
|
Score 0 (clear) |
1
3.7%
|
1
7.7%
|
Score 1 (mild) |
11
40.7%
|
5
38.5%
|
Score 2 (moderate) |
13
48.1%
|
6
46.2%
|
Score 3 (severe) |
2
7.4%
|
0
0%
|
Score 0 (clear) |
2
7.4%
|
1
7.7%
|
Score 1 (mild) |
8
29.6%
|
3
23.1%
|
Score 2 (moderate) |
13
48.1%
|
5
38.5%
|
Score 3 (severe) |
3
11.1%
|
3
23.1%
|
Adverse Events
Time Frame | Baseline up to Week 14 | |||
---|---|---|---|---|
Adverse Event Reporting Description | Safety population | |||
Arm/Group Title | ACU-D1 Ointment | ACU-D1 Ointment Vehicle | ||
Arm/Group Description | Twice-daily application of ACU-D1 ointment to the face for 12 weeks. | Twice-daily application of ACU-D1 ointment vehicle to the face for 12 weeks. | ||
All Cause Mortality |
||||
ACU-D1 Ointment | ACU-D1 Ointment Vehicle | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/27 (0%) | 0/13 (0%) | ||
Serious Adverse Events |
||||
ACU-D1 Ointment | ACU-D1 Ointment Vehicle | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/27 (0%) | 0/13 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
ACU-D1 Ointment | ACU-D1 Ointment Vehicle | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 11/27 (40.7%) | 4/13 (30.8%) | ||
Gastrointestinal disorders | ||||
Vomiting | 1/27 (3.7%) | 0/13 (0%) | ||
General disorders | ||||
Administration site dryness | 1/27 (3.7%) | 1/13 (7.7%) | ||
Administration site warmth | 1/27 (3.7%) | 0/13 (0%) | ||
Application site perspiration | 1/27 (3.7%) | 0/13 (0%) | ||
Infections and infestations | ||||
Ear infection | 1/27 (3.7%) | 0/13 (0%) | ||
Nasopharyngitis | 2/27 (7.4%) | 2/13 (15.4%) | ||
Respiratory tract infection | 1/27 (3.7%) | 0/13 (0%) | ||
Sinusitis | 1/27 (3.7%) | 0/13 (0%) | ||
Injury, poisoning and procedural complications | ||||
Tibia fracture | 1/27 (3.7%) | 0/13 (0%) | ||
Investigations | ||||
White blood cell count decreased | 0/27 (0%) | 1/13 (7.7%) | ||
Metabolism and nutrition disorders | ||||
Vitamin D deficiency | 1/27 (3.7%) | 0/13 (0%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Cough | 0/27 (0%) | 1/13 (7.7%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Chief Science Officer |
---|---|
Organization | Accuitis, Inc. |
Phone | 678-812-1492 |
info@accuitis.com |
- ACU-D1