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

NCT ID: NCT02279823

Last Updated: 2017-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CB-03-01 solution

Topical solution applied twice daily for 26 weeks

Group Type: EXPERIMENTAL

CB-03-01 solution

Intervention Type: DRUG

Investigational drug solution

Minoxidil Solution 5%

Topical solution applied twice daily for 26 weeks

Group Type: ACTIVE_COMPARATOR

Minoxidil Solution 5%

Intervention Type: DRUG

FDA approved marketed product

Placebo solution

Topical solution applied twice daily for 26 weeks

Group Type: PLACEBO_COMPARATOR

Placebo solution

Intervention Type: DRUG

Vehicle solution

Interventions

CB-03-01 solution

Investigational drug solution

Intervention Type: DRUG

Minoxidil Solution 5%

FDA approved marketed product

Intervention Type: DRUG

Placebo solution

Vehicle solution

Intervention Type: DRUG

Other Intervention Names

cortexolone 17α-propionate

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Subject has used the following systemic medications or procedures:

• Beta blockers, cimetidine, diazoxide, isotretinoin, vitamin A intake above 10000 IU per day or corticosteroids (including intramuscular and intralesional injections) within 12 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 4 weeks prior to the initiation of treatment)
• Retinoid, cyclosporine therapy within 6 months of the initiation of treatment
• Finasteride (Propecia®, etc.), dutasteride or a similar product(s) within 12 months of the initiation of treatment
• Chemotherapy, cytotoxic agents or radiation (of the scalp) within 12 months of the initiation of treatment
• Other systemic therapy which may materially affect the subject's hair or hair growth in the opinion of the investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Intrepid Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Andrasfay

Role: STUDY_DIRECTOR

Therapeutics, Inc.

Locations

Therapeutics Clinical Research

San Diego, California, United States

Minnesota Clinical Study Center

Fridley, Minnesota, United States

DermResearch, Inc.

Austin, Texas, United States

Countries

United States

Other Identifiers

171-7152-201

Identifier Type: -

Identifier Source: org_study_id