A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris
Study Details
Study Description
Brief Summary
CB-03-01 is being developed for the topical treatment of acne vulgaris, an androgen-dependent skin disorder. The purpose of this study is to compare the safety and efficacy of multiple concentrations of CB-03-01 to vehicle in the treatment of acne vulgaris.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Low-dose active, BID low dose of CB-03-01, 0.1% applied twice a day |
Drug: CB-03-01
Topical cream, applied twice a day
Other Names:
|
| Experimental: Medium-dose active, BID medium dose of CB-03-01, 0.5% applied twice a day |
Drug: CB-03-01
Topical cream, applied twice a day
Other Names:
|
| Experimental: High-dose active, QD high dose of CB-03-01, 1% applied once a day |
Drug: CB-03-01
Topical cream, applied once a day
Other Names:
|
| Experimental: High-dose active, BID high dose of CB-03-01, 1% applied twice a day |
Drug: CB-03-01
Topical cream, applied twice a day
Other Names:
|
| Placebo Comparator: Vehicle, QD or BID vehicle cream, applied once or twice a day |
Drug: Vehicle
Topical cream, applied once or twice a day
|
Outcome Measures
Primary Outcome Measures
- Investigator's Global Assessment (IGA) "Success" - Week 12 [Baseline and Week 12]
Count and percentage of subjects achieving success in each treatment group at Week 12 using the dichotomized IGA with success defined as a score of "clear" or "almost clear" (IGA Score of 0 or 1) and a two or more grade improvement from Baseline using a five-point scale (0=clear to 4=severe).
- Inflammatory and Non-Inflammatory Lesion Counts - Week 12 [Baseline and Week 12]
Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 12.
Secondary Outcome Measures
- Inflammatory and Non-Inflammatory Lesion Counts - Week 8 [Baseline and Week 8]
Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 8.
- Percent Change in Lesion Counts - Weeks 8 and 12 [Week 8 and Week 12]
Percent change from Baseline in lesion counts (inflammatory and noninflammatory) in each treatment group at Weeks 8 and 12.
- IGA "Success" - Week 8 [Baseline and Week 8]
Count and percentage of subjects achieving success per the IGA in each treatment group at Week 8 ("success" as defined in the primary endpoints section).
- IGA "Clear" or "Almost Clear" - Weeks 4, 8 and 12 [Weeks 4, 8, and 12]
Count and percentage of subjects who are "clear" or "almost clear" (IGA Grade 0 or 1) in each treatment group at Weeks 4, 8 and 12.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject is male or non-pregnant female. Females must be post-menopausal, surgically sterile or using highly effective birth control methods.
-
Subject has provided written and verbal informed consent/assent.
-
Subject has facial acne vulgaris (including the nose).
-
Subject is willing to comply with study instructions and return to the clinic for required visits.
-
Subject has used the same type and brand of make-up, other facial products (including cleanser) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the study start and agrees to continue his/her other general skin and hair care products and regimen for the entire study.
Exclusion Criteria:
-
Subject is pregnant, lactating, or is planning to become pregnant during the study.
-
Subject is currently enrolled in an investigational drug or device study.
-
Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the study start.
-
Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial
-
Subject has used any of the following topical anti-acne preparations or procedures on the face:
-
Topical anti-acne treatments including but not limited to over-the-counter acne cleaners or treatments, benzoyl peroxide, antibiotics, azelaic acid, sulfa based products, corticosteroids and salicylic acid within two weeks of the initiation of treatment.
-
Retinoids, including tazarotene, adapalene, tretinoin, within four weeks of the initiation of treatment.
-
Light treatments, microdermabrasion or chemical peels within eight weeks of the initiation of treatment.
-
Subject has used the following systemic anti-acne medications:
-
Corticosteroids (including intramuscular and intralesional injections) within four weeks of the initiation of treatment. Inhaled, intranasal or ocular corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least four weeks prior to the initiation of treatment).
-
Antibiotics within four weeks of the initiation of treatment with the exception of five days or less of antibiotic therapy during this period, but with no antibiotics use permitted within one week prior to the initiation of treatment.
-
Spironolactone within eight weeks of the initiation of treatment with the exception of five days or less of spironolactone therapy during this period, but with no spironolactone use permitted within one week prior to the initiation of treatment.
-
Retinoid therapy within six months of the initiation of treatment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dermatology Research Associates | Los Angeles | California | United States | 90045 |
| 2 | Therapeutics Clinical Research | San Diego | California | United States | 92123 |
| 3 | University Clinical Trials | San Diego | California | United States | 92123 |
| 4 | International Clinical Research - US, LLC | Sanford | Florida | United States | |
| 5 | Gwinnett Clinical Research Center, Inc. | Snellville | Georgia | United States | 30078 |
| 6 | Altman Dermatology Associates | Arlington Heights | Illinois | United States | 60005 |
| 7 | Indiana Clinical Trials Center | Plainfield | Indiana | United States | 46168 |
| 8 | Marina I. Peredo, M.D., PC | Smithtown | New York | United States | |
| 9 | Penn State Milton S. Hershey Medical Center - Dept. of Dermatology | Hershey | Pennsylvania | United States | 17033 |
| 10 | Clinical Partners, LLC | Johnston | Rhode Island | United States | |
| 11 | J & S Studies | College Station | Texas | United States | 77845 |
| 12 | UT Houston Health Science Center | Houston | Texas | United States | 77030 |
| 13 | Virginia Clinical Research | Norfolk | Virginia | United States | 23507 |
Sponsors and Collaborators
- Intrepid Therapeutics, Inc.
Investigators
- Study Director: R&D Cassiopea, Cassiopea S.p.A.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 171-7151-201
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Low-dose Active, BID | Medium-dose Active, BID | High-dose Active, QD | High-dose Active, BID | Vehicle, QD or BID |
|---|---|---|---|---|---|
| Arm/Group Description | low dose of CB-03-01, 0.1% applied twice a day CB-03-01: Topical cream, applied twice a day | medium dose of CB-03-01, 0.5% applied twice a day CB-03-01: Topical cream, applied twice a day | high dose of CB-03-01, 1% applied once a day CB-03-01: Topical cream, applied once a day | high dose of CB-03-01, 1% applied twice a day CB-03-01: Topical cream, applied twice a day | vehicle cream, applied once or twice a day Vehicle: Topical cream, applied once or twice a day |
| Period Title: Overall Study | |||||
| STARTED | 72 | 76 | 70 | 70 | 75 |
| COMPLETED | 58 | 64 | 61 | 59 | 62 |
| NOT COMPLETED | 14 | 12 | 9 | 11 | 13 |
Baseline Characteristics
| Arm/Group Title | Low-dose Active, BID | Medium-dose Active, BID | High-dose Active, QD | High-dose Active, BID | Vehicle, QD or BID | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | low dose of CB-03-01, 0.1% applied twice a day CB-03-01: Topical cream, applied twice a day | medium dose of CB-03-01, 0.5% applied twice a day CB-03-01: Topical cream, applied twice a day | high dose of CB-03-01, 1% applied once a day CB-03-01: Topical cream, applied once a day | high dose of CB-03-01, 1% applied twice a day CB-03-01: Topical cream, applied twice a day | vehicle cream, applied once or twice a day Vehicle: Topical cream, applied once or twice a day | Total of all reporting groups |
| Overall Participants | 72 | 76 | 70 | 70 | 75 | 363 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
19.8
(5.77)
|
20.4
(6.31)
|
18.3
(6.14)
|
21.0
(6.22)
|
19.2
(5.25)
|
19.7
(5.99)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
36
50%
|
42
55.3%
|
38
54.3%
|
37
52.9%
|
43
57.3%
|
196
54%
|
| Male |
36
50%
|
34
44.7%
|
32
45.7%
|
33
47.1%
|
32
42.7%
|
167
46%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||
| Hispanic or Latino |
22
30.6%
|
20
26.3%
|
6
8.6%
|
15
21.4%
|
13
17.3%
|
76
20.9%
|
| Not Hispanic or Latino |
50
69.4%
|
56
73.7%
|
64
91.4%
|
55
78.6%
|
62
82.7%
|
287
79.1%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||||
| American Indian or Alaska Native |
0
0%
|
1
1.3%
|
0
0%
|
2
2.9%
|
0
0%
|
3
0.8%
|
| Asian |
1
1.4%
|
3
3.9%
|
4
5.7%
|
4
5.7%
|
4
5.3%
|
16
4.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
1
1.3%
|
0
0%
|
0
0%
|
1
1.3%
|
2
0.6%
|
| Black or African American |
12
16.7%
|
14
18.4%
|
16
22.9%
|
20
28.6%
|
12
16%
|
74
20.4%
|
| White |
58
80.6%
|
54
71.1%
|
50
71.4%
|
42
60%
|
53
70.7%
|
257
70.8%
|
| More than one race |
1
1.4%
|
2
2.6%
|
0
0%
|
2
2.9%
|
4
5.3%
|
9
2.5%
|
| Unknown or Not Reported |
0
0%
|
1
1.3%
|
0
0%
|
0
0%
|
1
1.3%
|
2
0.6%
|
| Baseline IGA (Count of Participants) | ||||||
| 0 - Clear |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 1 - Almost clear |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| 2 - Mild |
10
13.9%
|
6
7.9%
|
15
21.4%
|
18
25.7%
|
11
14.7%
|
60
16.5%
|
| 3 - Moderate |
56
77.8%
|
62
81.6%
|
44
62.9%
|
32
45.7%
|
53
70.7%
|
247
68%
|
| 4 - Severe |
6
8.3%
|
8
10.5%
|
11
15.7%
|
20
28.6%
|
11
14.7%
|
56
15.4%
|
| Baseline lesions counts (lesions) [Mean (Full Range) ] | ||||||
| Inflammatory lesions |
29.9
|
29.0
|
31.9
|
28.6
|
30.5
|
30.0
|
| Non-inflammatory lesions |
43.5
|
44.5
|
46.7
|
47.2
|
43.9
|
45.2
|
Outcome Measures
| Title | Investigator's Global Assessment (IGA) "Success" - Week 12 |
|---|---|
| Description | Count and percentage of subjects achieving success in each treatment group at Week 12 using the dichotomized IGA with success defined as a score of "clear" or "almost clear" (IGA Score of 0 or 1) and a two or more grade improvement from Baseline using a five-point scale (0=clear to 4=severe). |
| Time Frame | Baseline and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per-Protocol Population, defined as a subset of the ITT population and included those subjects that met eligibility criteria, completed the end-of-study visit, and applied at least 80% of the expected treatment applications. |
| Arm/Group Title | Low-dose Active, BID | Medium-dose Active, BID | High-dose Active, QD | High-dose Active, BID | Vehicle, QD or BID |
|---|---|---|---|---|---|
| Arm/Group Description | low dose of CB-03-01, 0.1% applied twice a day CB-03-01: Topical cream, applied twice a day | medium dose of CB-03-01, 0.5% applied twice a day CB-03-01: Topical cream, applied twice a day | high dose of CB-03-01, 1% applied once a day CB-03-01: Topical cream, applied once a day | high dose of CB-03-01, 1% applied twice a day CB-03-01: Topical cream, applied twice a day | vehicle cream, applied once or twice a day Vehicle: Topical cream, applied once or twice a day |
| Measure Participants | 57 | 64 | 52 | 55 | 59 |
| Count of Participants [Participants] |
5
6.9%
|
3
3.9%
|
2
2.9%
|
6
8.6%
|
2
2.7%
|
| Title | Inflammatory and Non-Inflammatory Lesion Counts - Week 12 |
|---|---|
| Description | Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 12. |
| Time Frame | Baseline and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population. |
| Arm/Group Title | Low-dose Active, BID | Medium-dose Active, BID | High-dose Active, QD | High-dose Active, BID | Vehicle, QD or BID |
|---|---|---|---|---|---|
| Arm/Group Description | low dose of CB-03-01, 0.1% applied twice a day CB-03-01: Topical cream, applied twice a day | medium dose of CB-03-01, 0.5% applied twice a day CB-03-01: Topical cream, applied twice a day | high dose of CB-03-01, 1% applied once a day CB-03-01: Topical cream, applied once a day | high dose of CB-03-01, 1% applied twice a day CB-03-01: Topical cream, applied twice a day | vehicle cream, applied once or twice a day Vehicle: Topical cream, applied once or twice a day |
| Measure Participants | 55 | 62 | 52 | 55 | 57 |
| Inflammatory lesions |
-8.3
(14.63)
|
-5.8
(11.99)
|
-10.1
(12.53)
|
-12.3
(14.43)
|
-9.1
(13.67)
|
| Non-inflammatory lesions |
-8.7
(18.16)
|
-6.1
(29.22)
|
-8.4
(21.55)
|
-15.5
(20.48)
|
-6.7
(19.65)
|
| Title | Inflammatory and Non-Inflammatory Lesion Counts - Week 8 |
|---|---|
| Description | Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 8. |
| Time Frame | Baseline and Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population |
| Arm/Group Title | Low-dose Active, BID | Medium-dose Active, BID | High-dose Active, QD | High-dose Active, BID | Vehicle, QD or BID |
|---|---|---|---|---|---|
| Arm/Group Description | low dose of CB-03-01, 0.1% applied twice a day CB-03-01: Topical cream, applied twice a day | medium dose of CB-03-01, 0.5% applied twice a day CB-03-01: Topical cream, applied twice a day | high dose of CB-03-01, 1% applied once a day CB-03-01: Topical cream, applied once a day | high dose of CB-03-01, 1% applied twice a day CB-03-01: Topical cream, applied twice a day | vehicle cream, applied once or twice a day Vehicle: Topical cream, applied once or twice a day |
| Measure Participants | 54 | 62 | 52 | 53 | 56 |
| Inflammatory lesions |
-11.9
(8.84)
|
-7.2
(12.03)
|
-7.2
(17.21)
|
-11.5
(11.19)
|
-11.3
(12.71)
|
| Non-inflammatory lesions |
-7.0
(13.76)
|
-6.7
(16.33)
|
-3.2
(37.01)
|
-13.6
(17.99)
|
-8.3
(17.12)
|
| Title | Percent Change in Lesion Counts - Weeks 8 and 12 |
|---|---|
| Description | Percent change from Baseline in lesion counts (inflammatory and noninflammatory) in each treatment group at Weeks 8 and 12. |
| Time Frame | Week 8 and Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population |
| Arm/Group Title | Low-dose Active, BID | Medium-dose Active, BID | High-dose Active, QD | High-dose Active, BID | Vehicle, QD or BID |
|---|---|---|---|---|---|
| Arm/Group Description | low dose of CB-03-01, 0.1% applied twice a day CB-03-01: Topical cream, applied twice a day | medium dose of CB-03-01, 0.5% applied twice a day CB-03-01: Topical cream, applied twice a day | high dose of CB-03-01, 1% applied once a day CB-03-01: Topical cream, applied once a day | high dose of CB-03-01, 1% applied twice a day CB-03-01: Topical cream, applied twice a day | vehicle cream, applied once or twice a day Vehicle: Topical cream, applied once or twice a day |
| Measure Participants | 54 | 62 | 52 | 53 | 56 |
| Inflammatory lesions (Week 8) |
-40.6
(28.20)
|
-26.6
(37.35)
|
-27.5
(41.44)
|
-41.1
(36.54)
|
-36.0
(35.01)
|
| Inflammatory lesions (Week 12) |
-26.8
(50.78)
|
-21.3
(45.33)
|
-32.5
(35.51)
|
-41.8
(52.25)
|
-28.4
(41.88)
|
| Non-inflammatory lesions (Week 8) |
-18.3
(34.50)
|
-19.5
(36.49)
|
-10.5
(57.13)
|
-33.5
(39.26)
|
-24.3
(43.23)
|
| Non-inflammatory lesions (Week 12) |
-24.3
(38.69)
|
-16.9
(55.66)
|
-19.5
(40.75)
|
-34.1
(46.95)
|
-19.5
(47.43)
|
| Title | IGA "Success" - Week 8 |
|---|---|
| Description | Count and percentage of subjects achieving success per the IGA in each treatment group at Week 8 ("success" as defined in the primary endpoints section). |
| Time Frame | Baseline and Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population. |
| Arm/Group Title | Low-dose Active, BID | Medium-dose Active, BID | High-dose Active, QD | High-dose Active, BID | Vehicle, QD or BID |
|---|---|---|---|---|---|
| Arm/Group Description | low dose of CB-03-01, 0.1% applied twice a day CB-03-01: Topical cream, applied twice a day | medium dose of CB-03-01, 0.5% applied twice a day CB-03-01: Topical cream, applied twice a day | high dose of CB-03-01, 1% applied once a day CB-03-01: Topical cream, applied once a day | high dose of CB-03-01, 1% applied twice a day CB-03-01: Topical cream, applied twice a day | vehicle cream, applied once or twice a day Vehicle: Topical cream, applied once or twice a day |
| Measure Participants | 54 | 62 | 52 | 53 | 56 |
| Count of Participants [Participants] |
1
1.4%
|
3
3.9%
|
1
1.4%
|
4
5.7%
|
2
2.7%
|
| Title | IGA "Clear" or "Almost Clear" - Weeks 4, 8 and 12 |
|---|---|
| Description | Count and percentage of subjects who are "clear" or "almost clear" (IGA Grade 0 or 1) in each treatment group at Weeks 4, 8 and 12. |
| Time Frame | Weeks 4, 8, and 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol population. |
| Arm/Group Title | Low-dose Active, BID | Medium-dose Active, BID | High-dose Active, QD | High-dose Active, BID | Vehicle, QD or BID |
|---|---|---|---|---|---|
| Arm/Group Description | low dose of CB-03-01, 0.1% applied twice a day CB-03-01: Topical cream, applied twice a day | medium dose of CB-03-01, 0.5% applied twice a day CB-03-01: Topical cream, applied twice a day | high dose of CB-03-01, 1% applied once a day CB-03-01: Topical cream, applied once a day | high dose of CB-03-01, 1% applied twice a day CB-03-01: Topical cream, applied twice a day | vehicle cream, applied once or twice a day Vehicle: Topical cream, applied once or twice a day |
| Measure Participants | 57 | 64 | 52 | 55 | 59 |
| Week 4 |
3
4.2%
|
1
1.3%
|
5
7.1%
|
7
10%
|
2
2.7%
|
| Week 8 |
3
4.2%
|
4
5.3%
|
2
2.9%
|
6
8.6%
|
4
5.3%
|
| Week 12 |
6
8.3%
|
4
5.3%
|
3
4.3%
|
9
12.9%
|
4
5.3%
|
Adverse Events
| Time Frame | Adverse events (AEs) were collected from screening visit, Baseline (Day 1) and up to Week 12/early termination. | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | Low-dose Active, BID | Medium-dose Active, BID | High-dose Active, QD | High-dose Active, BID | Vehicle, QD or BID | |||||
| Arm/Group Description | low dose of CB-03-01, 0.1% applied twice a day CB-03-01: Topical cream, applied twice a day | medium dose of CB-03-01, 0.5% applied twice a day CB-03-01: Topical cream, applied twice a day | high dose of CB-03-01, 1% applied once a day CB-03-01: Topical cream, applied once a day | high dose of CB-03-01, 1% applied twice a day CB-03-01: Topical cream, applied twice a day | vehicle cream, applied once or twice a day Vehicle: Topical cream, applied once or twice a day | |||||
All Cause Mortality |
||||||||||
| Low-dose Active, BID | Medium-dose Active, BID | High-dose Active, QD | High-dose Active, BID | Vehicle, QD or BID | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/72 (0%) | 0/76 (0%) | 0/70 (0%) | 0/70 (0%) | 0/75 (0%) | |||||
Serious Adverse Events |
||||||||||
| Low-dose Active, BID | Medium-dose Active, BID | High-dose Active, QD | High-dose Active, BID | Vehicle, QD or BID | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/72 (0%) | 0/76 (0%) | 0/70 (0%) | 0/70 (0%) | 0/75 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Low-dose Active, BID | Medium-dose Active, BID | High-dose Active, QD | High-dose Active, BID | Vehicle, QD or BID | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/72 (16.7%) | 18/76 (23.7%) | 9/70 (12.9%) | 5/70 (7.1%) | 5/75 (6.7%) | |||||
| General disorders | ||||||||||
| Pyrexia | 0/72 (0%) | 0 | 2/76 (2.6%) | 2 | 2/70 (2.9%) | 2 | 0/70 (0%) | 0 | 0/75 (0%) | 0 |
| Infections and infestations | ||||||||||
| Upper respiratory tract infection | 6/72 (8.3%) | 6 | 8/76 (10.5%) | 8 | 2/70 (2.9%) | 2 | 3/70 (4.3%) | 3 | 2/75 (2.7%) | 2 |
| Nasopharyngitis | 1/72 (1.4%) | 1 | 0/76 (0%) | 0 | 4/70 (5.7%) | 4 | 1/70 (1.4%) | 1 | 0/75 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||
| Laceration | 2/72 (2.8%) | 2 | 1/76 (1.3%) | 1 | 0/70 (0%) | 0 | 0/70 (0%) | 0 | 0/75 (0%) | 0 |
| Nervous system disorders | ||||||||||
| Headache | 2/72 (2.8%) | 2 | 1/76 (1.3%) | 1 | 0/70 (0%) | 0 | 0/70 (0%) | 0 | 2/75 (2.7%) | 2 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Oropharyngeal pain | 1/72 (1.4%) | 1 | 4/76 (5.3%) | 4 | 1/70 (1.4%) | 1 | 0/70 (0%) | 0 | 0/75 (0%) | 0 |
| Nasal congestion | 0/72 (0%) | 0 | 2/76 (2.6%) | 2 | 0/70 (0%) | 0 | 1/70 (1.4%) | 1 | 1/75 (1.3%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 18 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review 60 days prior to public disclosure. The PI may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Cassiopea R&D |
|---|---|
| Organization | Cassiopea, SpA |
| Phone | +39 02 868 911 24 |
| r&d@cassiopea.com |
- 171-7151-201