A Study to Evaluate the Safety and Efficacy of CB-03-01 Cream, 1% in Subjects With Facial Acne Vulgaris (25)

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: NCT02608450
• Other study ID #: CB-03-01/25
• Status: Completed
• Phase: Phase 3
• Start date: January 21, 2016
• Est. completion date: April 11, 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: 708
• Est. completion date: April 11, 2018
• Est. primary completion date: April 11, 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
Georgia	Site 9911	Tbilisi
Georgia	Site 9912	Tbilisi
Georgia	Site 9913	Tbilisi
Ukraine	Site 3802	Dnipro
Ukraine	3808	Kharkiv
Ukraine	Site 3804	Kharkiv
Ukraine	Site 3801	Kyiv
Ukraine	3807	Lviv
Ukraine	Site 3803	Ternopil'
Ukraine	Site 3809	Zaporizhzhya
United States	Westlake Dermatology Clinical Research Center	Austin	Texas
United States	Bellaire Dermatology Associates	Bellaire	Texas
United States	Site 0190	Boca Raton	Florida
United States	Study Protocol, Inc.	Boynton Beach	Florida
United States	Site 0152	Carmel	Indiana
United States	J&S Studies, Inc.	College Station	Texas
United States	Horizons Clinical Research Center, LLC	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	Center For Dermatology Clinical Research, Inc.	Fremont	California
United States	Greenville Dermatology, LLC	Greenville	South Carolina
United States	The Pennsylvania State University and the Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	Gary M. Petrus, MD PA	Little Rock	Arkansas
United States	Vitiligo & Pigmentation Institute of Southern California	Los Angeles	California
United States	Site 0191	Miami	Florida
United States	Site 0192	Miami	Florida
United States	Site 0195	Miami	Florida
United States	Site 0196	Miami	Florida
United States	Site 0197	Miami	Florida
United States	Site 0198	Miami	Florida
United States	Site 0199	Miami	Florida
United States	The Center for Dermatology, Cosmetic & Laser Surgery	Mount Kisco	New York
United States	International Clinical Research - Tennessee LLC	Murfreesboro	Tennessee
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	MedaPhase, Inc.	Newnan	Georgia
United States	Clinical Research Associates of Tidewater, Inc.	Norfolk	Virginia
United States	Tory Sullivan, M.D., P.A.	North Miami Beach	Florida
United States	Austin Institute for Clinical Research, Inc.	Pflugerville	Texas
United States	The Indiana Clinical Trials Center	Plainfield	Indiana
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Wake Research Associates	Raleigh	North Carolina
United States	MediSearch Clinical Trials	Saint Joseph	Missouri
United States	Meridien Research	Saint Petersburg	Florida
United States	Rady Childrens Hospital, Pediatric and Adolescent Dermatology	San Diego	California
United States	San Diego Sports Medicine and Family Health Center	San Diego	California
United States	Southern California Dermatology	Santa Ana	California
United States	Clinical Science Institute	Santa Monica	California
United States	Dermatology Associates	Seattle	Washington
United States	Premier Clinical Research	Spokane	Washington
United States	DermResearch Center of New York, Inc.	Stony Brook	New York
United States	MOORE Clinical Research, Inc.	Tampa	Florida
United States	Memorial Research Medical Clinic dba / Orange County Research Center	Tustin	California
United States	Omega Medical Research	Warwick	Rhode Island
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Cassiopea SpA

Countries where clinical trial is conducted

United States,  Georgia,  Ukraine, 

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 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 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 (NIL) 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 (IL) Counts	Percent change from Baseline in inflammatory lesions count in each treatment group at Week 12.	Baseline and Week 12

External Links

•   Study Website