A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title:

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Dose Escalating Study to Evaluate the Safety and Efficacy of Cortexolone 17a-Propionate (CB-03-01) Cream Applied Once or Twice-Daily for 12 Weeks in Subjects With Facial Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631474
• Other study ID #: 171-7151-201
• Status: Completed
• Phase: Phase 2
• Start date: June 2012
• Est. completion date: February 2014

Study information

• Verified date: October 2020
• Source: Intrepid Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• CB-03-01
Topical cream, applied once a day
• Vehicle
Topical cream, applied once or twice a day
• CB-03-01
Topical cream, applied twice a day

Locations

Country	Name	City	State
United States	Altman Dermatology Associates	Arlington Heights	Illinois
United States	J & S Studies	College Station	Texas
United States	Penn State Milton S. Hershey Medical Center - Dept. of Dermatology	Hershey	Pennsylvania
United States	UT Houston Health Science Center	Houston	Texas
United States	Clinical Partners, LLC	Johnston	Rhode Island
United States	Dermatology Research Associates	Los Angeles	California
United States	Virginia Clinical Research	Norfolk	Virginia
United States	Indiana Clinical Trials Center	Plainfield	Indiana
United States	Therapeutics Clinical Research	San Diego	California
United States	University Clinical Trials	San Diego	California
United States	International Clinical Research - US, LLC	Sanford	Florida
United States	Marina I. Peredo, M.D., PC	Smithtown	New York
United States	Gwinnett Clinical Research Center, Inc.	Snellville	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Intrepid Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator's Global Assessment (IGA) "Success" - 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).	Baseline and Week 12
Primary	Inflammatory and Non-Inflammatory Lesion Counts - Week 12	Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 12.	Baseline and Week 12
Secondary	Inflammatory and Non-Inflammatory Lesion Counts - Week 8	Absolute change from Baseline in inflammatory and non-inflammatory lesion counts in each treatment group at Week 8.	Baseline and Week 8
Secondary	Percent Change in Lesion Counts - Weeks 8 and 12	Percent change from Baseline in lesion counts (inflammatory and noninflammatory) in each treatment group at Weeks 8 and 12.	Week 8 and Week 12
Secondary	IGA "Success" - 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).	Baseline and Week 8
Secondary	IGA "Clear" or "Almost Clear" - 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.	Weeks 4, 8, and 12