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
Status: | Completed |
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Conditions: | Dermatology, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 6/17/2016 |
Start Date: | October 2014 |
End Date: | May 2016 |
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)
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.
investigated in male subjects with androgenetic alopecia (AGA) after twice daily application
for up to 26 weeks.
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
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