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

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Brief Title

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

Official Title

A Phase 2, Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Solution 5%, Minoxidil Solution 5%, and Vehicle Solution, Applied Twice-daily for 26 Weeks in Males With Androgenetic Alopecia (AGA)

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change in Target Area Hair Count (TAHC)

Secondary Outcome

 Change in Target Area Hair Width (TAHW)

Condition

Androgenetic Alopecia

Intervention

CB-03-01 solution

Study Arms / Comparison Groups

 CB-03-01 solution
Description:  Topical solution applied twice daily for 26 weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

95

Start Date

October 2014

Completion Date

May 2016

Primary Completion Date

December 2015

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
      

Gender

Male

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

Anthony Andrasfay, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02279823

Organization ID

171-7152-201


Responsible Party

Sponsor

Study Sponsor

Intrepid Therapeutics, Inc.


Study Sponsor

Anthony Andrasfay, Study Director, Therapeutics, Inc.


Verification Date

March 2017