A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (26)

Acne Vulgaris Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice Daily for 12 Weeks in Subjects With Facial Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608476
• Other study ID #: CB-03-01/26
• Status: Completed
• Phase: Phase 3
• Start date: November 16, 2015
• Est. completion date: February 21, 2018

Study information

• Verified date: October 2020
• Source: Cassiopea SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine the safety and efficacy of CB-03-01 cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 732
• Est. completion date: February 21, 2018
• Est. primary completion date: February 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

Inclusion Criteria:

1. Subject is male or non-pregnant female, 9 years of age or older. Females must be post-menopausal, surgically sterile, or using highly effective birth control methods. Women of child-bearing potential must have a negative urine pregnancy test (UPT) at the Screening/Baseline Visit.

2. Subject has provided written and verbal informed consent/assent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing.

3. Subject has an Investigator's Global Assessment (IGA) score of 3 (moderate) or 4 (severe) [0 (clear) to 4 (severe) scale].

4. Subject has facial acne vulgaris with at least 30 to a maximum of 75 inflammatory lesions (papules, pustules, and nodules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones).

5. Subject and parent/guardian (if applicable) are willing to comply with study instructions and return to the clinic for required visits.

6. Subject has used the same type and brand of make-up, other facial products (exclusive of RX/OTC acne cleansers) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one (1) month prior to the Baseline Visit and agrees to continue his/her other general skin and hair care products and regimen for the entire study.

Exclusion Criteria:

1. Subject is pregnant, lactating, or is planning to become pregnant during the study.

2. Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.

3. Subject has greater than two (2) facial nodules.

4. Subject has nodulocystic acne.

5. Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.

6. Subject is currently enrolled in an investigational drug or device study.

7. Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (Baseline).

8. Subject has facial hair that could interfere with the study assessments in the opinion of the investigator.

9. Subject and parent/guardian (if applicable) are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.

10. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.

11. Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.

12. Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.

13. Subject has used any of the prohibited topical anti-acne treatments or procedures prior to the study unless appropriate washout period is documented.

14. Subject has used used any of the prohibited systemic anti-acne medications prior to the study unless appropriate washout period is documented.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• CB-03-01 cream, 1%
CB-03-01 (cortexolone 17a-propionate) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.
• Vehicle cream
Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17a-propionate.

Locations

Country	Name	City	State
Bulgaria	Site 3521	Plovdiv
Bulgaria	3520	Sofia
Bulgaria	Site 3519	Sofia
Bulgaria	Site 3523	Sofia
Bulgaria	Site 3524	Sofia
Bulgaria	Site 3525	Sofia
Bulgaria	Site 3526	Sofia
Bulgaria	Site 3522	Varna
Georgia	Site 9923	Batumi
Georgia	Site 9924	Kutaisi
Georgia	Site 9920	Tbilisi
Georgia	Site 9921	Tbilisi
Georgia	Site 9922	Tbilisi
Georgia	Site 9925	Zugdidi
Poland	4819	Bydgoszcz
Poland	Site 4814	Czestochowa
Poland	Site 4822	Czestochowa
Poland	4815	Katowice
Poland	Site 4811	Katowice
Poland	Site 4813	Kraków
Poland	Site 4815	Kraków
Poland	Site 4821	Kraków
Poland	Site 4820	Lódz
Poland	Site 4823	Osielsko
Poland	Site 4816	Rzeszów
Poland	Site 4812	Szczecin
Poland	Site 4818	Warszawa
Romania	Site 4036	Bucarest
Romania	Site 4035	Bucharest
Romania	Site 4032	Craiova
Romania	Site 4037	Iasi
Romania	Site 4033	Sector 2	Bucharest
Romania	Site 4034	Sector 2	Bucharest
Romania	Site 4031	Sector 3	Bucharest
Romania	Site 4029	Sector 6	Bucharest
Romania	Site 4030	Sibiu
Romania	Site 4028	Târgoviste	Jud. Dambovita
Serbia	Site 8137	Belgrade
Serbia	Site 8138	Belgrade
Serbia	Site 8136	Novi Sad
United States	Arlington Dermatology	Arlington Heights	Illinois
United States	Johnson Dermatology	Fort Smith	Arkansas
United States	Maryland Laser Skin and Vein Institute	Hunt Valley	Maryland
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	Sadick Research Group, LLC	New York	New York
United States	Skin Specialty Dermatology	New York	New York
United States	Kansas City Dermatology, PA	Overland Park	Kansas
United States	Belleair Research Center	Pinellas Park	Florida
United States	Center for Dermatology and Laser Surgery	Sacramento	California
United States	Progressive Clinical Research, PA	San Antonio	Texas
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	Clear dermatology & Aesthetic Center	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Cassiopea SpA

Countries where clinical trial is conducted

United States,  Bulgaria,  Georgia,  Poland,  Romania,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Local Site Reactions	Local Site Reactions (LSRs) including telangiectasia, skin atrophy, striae rubrae, erythema, edema, scaling/dryness, stinging/burning, and pruritus scored by frequency and severity at every visit (Baseline, Weeks 4, 8, and 12).	Baseline, Weeks 4, 8, and 12
Primary	Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)	Percentage of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.	Week 12
Primary	Change From Baseline in Non-inflammatory Lesion (NIL) Counts	Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.	Baseline and Week 12
Primary	Change From Baseline in Inflammatory Lesion (IL) Counts	Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.	Baseline and Week 12
Secondary	Change From Baseline in Total Lesion Counts	Absolute change from Baseline in total lesions counts in each treatment group at Week 12.	Baseline and Week 12
Secondary	Percent Change From Baseline in Total Lesion Counts	Percent change from Baseline in total lesions counts in each treatment group at Week 12.	Baseline and Week 12
Secondary	Percent Change From Baseline in Non-inflammatory Lesion Counts	Percent change from Baseline in non-inflammatory lesions count in each treatment group at Week 12.	Baseline and Week 12
Secondary	Percent Change From Baseline in Inflammatory Lesion Counts	Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.	Baseline and Week 12

External Links

•   Study Website