A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia

NCT02279823 | Completed Phase 2

• 1 other identifier: 171-7152-201
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 3

Brief Summary

In this proof-of-concept study, the safety and efficacy of a solution formulation will be investigated in male subjects with androgenetic alopecia (AGA) after twice daily application for up to 26 weeks.

Conditions

Androgenetic Alopecia

Keywords

androgen; alopecia; CB-03-01; solution; topical

Outcome Measures

Primary Outcomes (2)

• Change in Target Area Hair Count (TAHC)

  Changes from Baseline in TAHC \[in number of non-vellus hairs\] using digital image analysis at Month 6.

  Baseline and Month 6

• Subject Self Assessment (Hair Growth Assessment [HGA])

  The subject's evaluation of treatment benefit via the HGA questionnaires at Month 6. Scalp hair growth is compared from baseline using the following 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3).

  Month 6

Secondary Outcomes (4)

• Change in Target Area Hair Width (TAHW)

  Baseline and Month 6

• Change in Target Area Hair Density (TAHD)

  Baseline and Month 6

• Subject evaluation of treatment benefit via the Hair Growth Index (HGI) and Hair Growth Satisfaction Scale (HGSS) questionnaires

  Month 6

• Investigator's Global Assessment (IGA)

  Baseline, Month 2, 4 and 6

Study Arms (3)

CB-03-01 solution

EXPERIMENTAL

Topical solution applied twice daily for 26 weeks

Drug: CB-03-01 solution

Minoxidil Solution 5%

ACTIVE COMPARATOR

Topical solution applied twice daily for 26 weeks

Drug: Minoxidil Solution 5%

Placebo solution

PLACEBO COMPARATOR

Topical solution applied twice daily for 26 weeks

Drug: Placebo solution

Interventions

CB-03-01 solution DRUG

Investigational drug solution

Also known as: cortexolone 17α-propionate

CB-03-01 solution

Minoxidil Solution 5% DRUG

FDA approved marketed product

Minoxidil Solution 5%

Placebo solution DRUG

Vehicle solution

Placebo solution

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject has mild to moderate androgenetic alopecia (AGA) in temple and vertex region
• Subject is willing to maintain the same hairstyle, hair length, and hair color throughout the study
• Subject agrees to continue his other general hair care products and regimen for the entire study
• Subjects who are sexually active with a female partner must be surgically sterile or agree to use an effective method of birth control from the first administration of the test article until 30 days after the last administration

You may not qualify if:

• Subject has any dermatological disorders of the scalp in the target region with the possibility of interfering with the application of the test article or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy
• Subject has any condition in the opinion of the investigator that could interfere with the evaluation of the test articles or requires the use of interfering topical or systemic therapy (e.g., uncontrolled thyroid disease, certain genetic disorders that involve hair growth or patterns)
• Subject has a current or recent history (within 3 months) of hair transplants, hair weaves or non-breathable wigs and hair bonding
• Subject has a current or recent history (within 3 months) of active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania or conditions/diseases other than AGA
• Subject has a current or recent history (within 3 months) of severe dietary changes or presenting a history of eating disorder(s)
• Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research 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 initiation of treatment
• Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
• 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
• The subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles or tattoo ink
• Subject has used any of the following topical preparations or procedures on the scalp:
• Topical treatments including corticosteroids, pimecrolimus, tacrolimus, minoxidil, hormone therapy, anti-androgens or other agents that are known to affect hair growth in the opinion of the investigator within 12 weeks of the initiation of treatment
• Topical over-the-counter (OTC) or cosmetic treatments known or reasonably believed to affect hair growth (e.g., brands such as Aminexil, Maxilene, Nioxin, Foltene, etc. or hair health or hair growth products with saw palmetto, copper, etc.) in the opinion of the investigator within 4 weeks of the initiation of treatment.
• Scalp procedures (surgical, laser, light or energy treatments, etc.) within 6 months of the initiation of treatment

Sponsors & Collaborators

• Intrepid Therapeutics, Inc.: lead

Study Sites (3)

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

Clascoterone

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Anthony Andrasfay

  Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 31, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2016
• Last Updated: March 13, 2017

Record last verified: 2017-03

Locations

US (3)