Clinical trial NCT01631474: A Phase 2 Dose Escalating Study to Evaluate the Safety and Efficacy of CB-03-01 Cream in Subjects With Facial Acne Vulgaris
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: acne
anti-androgen
clascoterone
cassiopea
Lead sponsor: Intrepid Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-06-29
Enrollment: 363
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Investigator's Global Assessment (IGA) "Success" - Week 12
timeFrame: Baseline and Week 12
measure: Inflammatory and Non-Inflammatory Lesion Counts - Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Inflammatory and Non-Inflammatory Lesion Counts - Week 8
timeFrame: Baseline and Week 8
measure: Percent Change in Lesion Counts - Weeks 8 and 12
timeFrame: Week 8 and Week 12
measure: IGA "Success" - Week 8
timeFrame: Baseline and Week 8
measure: IGA "Clear" or "Almost Clear" - Weeks 4, 8 and 12
timeFrame: Weeks 4, 8, and 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: San Diego
country: United States
facility: University Clinical Trials
state: California
city: Sanford
country: United States
facility: International Clinical Research - US, LLC
state: Florida
city: Snellville
country: United States
facility: Gwinnett Clinical Research Center, Inc.
state: Georgia
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Plainfield
country: United States
facility: Indiana Clinical Trials Center
state: Indiana
city: Smithtown
country: United States
facility: Marina I. Peredo, M.D., PC
state: New York
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center - Dept. of Dermatology
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: College Station
country: United States
facility: J & S Studies
state: Texas
city: Houston
country: United States
facility: UT Houston Health Science Center
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
Study officials:
affiliation: Cassiopea S.p.A.
name: R&D Cassiopea
role: STUDY_DIRECTOR
References: