The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color

• Sponsor: Derm Research, PLLC (Other)
• Overall Status: Completed
• CT.gov ID: NCT03402893
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arm: 1
• Actual Duration (Months): 7.1
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

This is a single-center, open label pilot study. The study is comprised of 5 study visits; Screening, Baseline, and Weeks 4, 8, and 16. All subjects will receive Onexton at Baseline and be instructed to apply the gel once daily to the face. The investigators will evaluate Investigator Global Assessment of acne (IGA), total lesion count, inflammatory lesion count, non-inflammatory lesion count, Investigator Global Assessment of Post-Inflammatory Hyperpigmentation and distribution of Post-Inflammatory Hyperpigmentation, adverse events and concomitant medications.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris; Post Inflammatory Hyperpigmentation	Drug: ONEXTON Topical Gel	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color
• Actual Study Start Date: Jul 28, 2017
• Actual Primary Completion Date: Nov 15, 2017
• Actual Study Completion Date: Feb 28, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: single arm Onexton gel application Onexton gel will be supplied to all subjects and applied once daily to the face	Drug: ONEXTON Topical Gel; Onexton gel applied once daily to face

Outcome Measures

Primary Outcome Measures

1. Investigator Global Assessment Scale for Severity of Facial Acne [Week 4, Week 8, Week 16]

   Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for facial acne; the IGA scale for acne reflects the Investigator's assessment of the severity of a subject's acne on a scale from 0 to 5 with 0 = Clear Skin, 1 = Almost Clear, 2 = Mild, 3 = Moderate severity, 4 = Severe, 5 = Very Severe Each of these gradations is based upon a lesion count by the Investigator.

2. Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation [Week 4, Week 8, Week 16]

   Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for severity of post inflammatory hyperpigmentation; the IGA scale of post-inflammatory hyperpigmentation reflects the Investigator's assessment of the severity of a subject's hyperpigmentation on a scale from 0 to 6 with 0 = None, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = moderately Severe, 5 = Severe, 6 = Very severe Each of these gradations is based upon the investigator's impression

Secondary Outcome Measures

1. Percent Change in Inflammatory Lesions [Week 4, Week 8, Week 16]

   The Investigator will count the number of facial (from hairline to mandibular line) inflammatory acne lesions at each study visit. Inflammatory lesions include papules, pustules and nodules.

2. Percent Change in Non-inflammatory Lesion Count [Week 4, Week 8, Week 16]

   The Investigator will count the number of facial non-inflammatory acne lesions at each study visit. these include open and closed comedones.

3. Percent Change in Total Lesion Count [week 4, Week 8, Week 16]

   The Investigator will count the number of facial inflammatory and non-inflammatory acne lesions at each study visit. These include papules, pustules, nodules, and open and closed comedones.

4. Post-Inflammatory Hyperpigmentation (PIH) Distribution [baseline, Week 4, week 8, week 16]

   This measure as assessed by the Investigator seeks to quantify the extent to which post-inflammatory hyperpigmentation is distributed across the face, wherein 0= No PIH, 1=1-10% of the face affected, 2=11-20%, 3=21-30%, 4=31-40%, 5=41-50%, and 6=More than 50% of the face. Lower numbers reflect less severe disease.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Outpatient, subjects of skin of color, age 12 or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study;

A female is considered of childbearing potential unless she is:

• postmenopausal for at least 12 months prior to study drug administration

• without a uterus and/or both ovaries; or

• has been surgically sterile for at least 6 months prior to study drug administration

Reliable methods of contraception are:

• intrauterine device in use ≥ 90 days prior to study drug administration;

• barrier methods plus spermicide in use at least 14 days prior to study drug administration; or

• vasectomized partner

[Exception: Female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.]

1. Facial acne vulgaris in patients with skin of color (Fitzpatrick Type V & VI Supplement

VI) characterized by the following:

• IGA Score for acne vulgaris 3

• IGA Score for PIH 3

1. Able to understand and comply with the requirements of the study and sign Informed Consent /HIPAA Authorization forms

Exclusion Criteria:

1. Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control

2. Allergy/sensitivity to any component of the test treatment

3. IGA score for acne of 2 (mild) or 4 (severe)

4. IGA score for Post Inflammatory Hyperpigmentation of 2 (mild) or 4 (severe)

5. Subjects who have not complied with the proper wash-out periods for prohibited medications (Supplement I).

6. Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study

7. Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris

8. Evidence of recent alcohol or drug abuse

9. History of poor cooperation, non-compliance with medical treatment, or unreliability

10. Exposure to an investigational study drug within 30 days of the Baseline Visit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DermResearch, PLLC	Louisville	Kentucky	United States	40217

Sponsors and Collaborators

• Derm Research, PLLC

Investigators

None specified.

Study Documents (Full-Text)

• Informed Consent Form - Jun 12, 2017
• Study Protocol and Statistical Analysis Plan - Jan 31, 2017

More Information

Publications

None provided.

• Responsible Party: L.H. Kircik, M.D., Medical Director, Derm Research, PLLC
• ClinicalTrials.gov Identifier: NCT03402893
• Other Study ID Numbers: ONX-1701
• First Posted: Jan 18, 2018
• Last Update Posted: Apr 2, 2019
• Last Verified: Mar 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Acne Vulgaris; Hyperpigmentation

Study Results

Participant Flow

Pre-assignment Detail	1 participant signed consent but failed screening

Arm/Group Title	Onexton Gel Application
Arm/Group Description	Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face ONEXTON Topical Gel: Onexton gel applied once daily to face
Period Title: Overall Study
STARTED	21
COMPLETED	20
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Onexton Gel Application
Arm/Group Description	Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face ONEXTON Topical Gel: Onexton gel applied once daily to face
Overall Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32 (17)
Sex: Female, Male (Count of Participants)
Female	16 80%
Male	4 20%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	20 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	20 100%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	20 100%
Facial Investigator Global Assessment of Disease Severity (Count of Participants)
Moderate	20 100%
Clear	0 0%
Almost Clear	0 0%
Mild	0 0%
Severe	0 0%
Inflammatory Lesion Count (lesion) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [lesion]	14 (5)
Non-Inflammatory Lesion Count (lesion) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [lesion]	15 (4)
Post Inflammatory Hyperpigmentation Distribution (Count of Participants)
1-10%	2 10%
11-20%	3 15%
21-30%	6 30%
31-40%	4 20%
41-50%	3 15%
over 50%	2 10%
Total Lesion Count (lesion) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [lesion]	29 (4)
Investigator Global Assessment of Severity of Facial Post Inflammatory Hyperpigmentation (Count of Participants)
None	0 0%
Slight	0 0%
Mild	0 0%
Moderate	20 100%
Moderately Severe	0 0%

Outcome Measures

1. Primary Outcome

Title	Investigator Global Assessment Scale for Severity of Facial Acne
Description	Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for facial acne; the IGA scale for acne reflects the Investigator's assessment of the severity of a subject's acne on a scale from 0 to 5 with 0 = Clear Skin, 1 = Almost Clear, 2 = Mild, 3 = Moderate severity, 4 = Severe, 5 = Very Severe Each of these gradations is based upon a lesion count by the Investigator.
Time Frame	Week 4, Week 8, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Onexton Gel Application
Arm/Group Description	Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face ONEXTON Topical Gel: Onexton gel applied once daily to face
Measure Participants	20
clear	0 0%
almost clear	0 0%
mild	11 55%
moderate	9 45%
severe	0 0%
clear	0 0%
almost clear	6 30%
mild	12 60%
moderate	2 10%
severe	0 0%
clear	1 5%
almost clear	13 65%
mild	6 30%
moderate	0 0%
severe	0 0%

2. Primary Outcome

Title	Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
Description	Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for severity of post inflammatory hyperpigmentation; the IGA scale of post-inflammatory hyperpigmentation reflects the Investigator's assessment of the severity of a subject's hyperpigmentation on a scale from 0 to 6 with 0 = None, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = moderately Severe, 5 = Severe, 6 = Very severe Each of these gradations is based upon the investigator's impression
Time Frame	Week 4, Week 8, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Onexton Gel Application
Arm/Group Description	Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face ONEXTON Topical Gel: Onexton gel applied once daily to face
Measure Participants	20
none	0 0%
slight	2 10%
mild	17 85%
moderate	1 5%
moderately severe	0 0%
none	0 0%
slight	2 10%
mild	15 75%
moderate	2 10%
moderately severe	1 5%
none	0 0%
slight	8 40%
mild	11 55%
moderate	1 5%
moderately severe	0 0%

3. Secondary Outcome

Title	Percent Change in Inflammatory Lesions
Description	The Investigator will count the number of facial (from hairline to mandibular line) inflammatory acne lesions at each study visit. Inflammatory lesions include papules, pustules and nodules.
Time Frame	Week 4, Week 8, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Onexton Gel Application
Arm/Group Description	Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face ONEXTON Topical Gel: Onexton gel applied once daily to face
Measure Participants	20
Week 4	-35 (17)
Week 8	-55 (22)
Week 16	-76 (14)

4. Secondary Outcome

Title	Percent Change in Non-inflammatory Lesion Count
Description	The Investigator will count the number of facial non-inflammatory acne lesions at each study visit. these include open and closed comedones.
Time Frame	Week 4, Week 8, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Onexton Gel Application
Arm/Group Description	Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face ONEXTON Topical Gel: Onexton gel applied once daily to face
Measure Participants	20
week 4	-21 (22)
week 8	-41 (33)
week 16	-62 (32)

5. Secondary Outcome

Title	Percent Change in Total Lesion Count
Description	The Investigator will count the number of facial inflammatory and non-inflammatory acne lesions at each study visit. These include papules, pustules, nodules, and open and closed comedones.
Time Frame	week 4, Week 8, Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Onexton Gel Application
Arm/Group Description	Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face ONEXTON Topical Gel: Onexton gel applied once daily to face
Measure Participants	20
week 4	-29 (17)
week 8	-51 (21)
week 16	-71 (13)

6. Secondary Outcome

Title	Post-Inflammatory Hyperpigmentation (PIH) Distribution
Description	This measure as assessed by the Investigator seeks to quantify the extent to which post-inflammatory hyperpigmentation is distributed across the face, wherein 0= No PIH, 1=1-10% of the face affected, 2=11-20%, 3=21-30%, 4=31-40%, 5=41-50%, and 6=More than 50% of the face. Lower numbers reflect less severe disease.
Time Frame	baseline, Week 4, week 8, week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm Onexton Gel Application
Arm/Group Description	Onexton gel will be supplied to all subjects and applied once daily to the face ONEXTON Topical Gel: Onexton gel applied once daily to face
Measure Participants	20
0	0 0%
1	2 10%
2	3 15%
3	6 30%
4	4 20%
5	3 15%
6	2 10%
0	0 0%
1	2 10%
2	3 15%
3	7 35%
4	3 15%
5	3 15%
6	2 10%
0	0 0%
1	2 10%
2	4 20%
3	8 40%
4	3 15%
5	2 10%
6	1 5%
0	0 0%
1	5 25%
2	5 25%
3	5 25%
4	4 20%
5	1 5%
6	0 0%

Adverse Events

Time Frame	screening to week 16
Arm/Group Title	Onexton Gel Application
Arm/Group Description	Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face ONEXTON Topical Gel: Onexton gel applied once daily to face
All Cause Mortality
	Onexton Gel Application
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Onexton Gel Application
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Onexton Gel Application
	Affected / at Risk (%)	# Events
Total	10/20 (50%)
Ear and labyrinth disorders
serous otitis media	1/20 (5%)	1
General disorders
headache	2/20 (10%)	2
Infections and infestations
group A beta hemolytic strep pharyngitis	1/20 (5%)	1
cellulitis right knee	1/20 (5%)	1
Musculoskeletal and connective tissue disorders
intermittent mid back pain	1/20 (5%)	1
chest soreness	1/20 (5%)	1
maxillary fracture	1/20 (5%)	1
Reproductive system and breast disorders
unexpected menses	1/20 (5%)	1
bacterial vaginosis	1/20 (5%)	1
Respiratory, thoracic and mediastinal disorders
bronchitis	1/20 (5%)	1
pneumonia	1/20 (5%)	1
rhinorrhea	3/20 (15%)	3
cough	1/20 (5%)	1
upper respiratory infection	2/20 (10%)	2
Skin and subcutaneous tissue disorders
pharyngitis	2/20 (10%)	2
facial tattoo tightening	1/20 (5%)	1

Limitations/Caveats

[Not Specified]

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.