AGA (androgenic alopecia) is scalp hair loss that occurs due to an underlying susceptibility of hair follicles to androgenic miniaturization. In the hair follicle, testosterone is converted by 5a-reductase into 5a-dihydrotestosterone (DHT). The DHT level is increased in the balding scalp and may be the more relevant androgen for AGA pathogenesis. Thus, blocking or inhibiting the effect of DHT with the local application of antiandrogens may be an effective treatment for AGA.
Conditions
Interventions
Product Code: CB-03-01 solution, 2.5%
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: 21-dihydroxypregn-4-ene-3, 20-dione
CAS Number: 19608
Sponsors
Cassiopea S.p.A.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Subject is male, 18-55 years old. 2. Subject has provided written informed consent. 3. Subject has mild to moderate AGA in temple and vertex region, rating III vertex to V on the Modified Norwood-Hamilton Scale (i.e., IIIv, IV, or V), with a history of ongoing hair loss. 4. Subject is willing to maintain the same hairstyle, hair length, and hair color throughout the study. 5. Subject is willing to comply with study instructions and return to the clinic for required visits. 6. Subject agrees to continue his other general hair care products and regimen for the entire study. 7. Subjects who are sexually active with a female partner and are not surgically sterile (vasectomy performed at least six months prior to treatment) must agree to inform their female sexual partner to use an acceptable form of birth control as described in the informed consent form. For females, an acceptable method (Pearl Index =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject has any dermatological disorders of the scalp in the target region with the possibility of interfering with the application of the IMP or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy. 2. Subject has any skin pathology or condition that, in the investigator’s opinion, could interfere with the evaluation of the IMP or requires use of interfering topical, systemic (e.g., uncontrolled thyroid disease, certain genetic disorders that involve hair growth or patterns), or surgical therapy. 3. Subject has current or recent history (within 12 months) of hair weaves, non-breathable wigs, or hair bonding. 4. Subject had scalp hair transplants at any time. 5. Subject has a history or active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/diseases other than AGA. 6. Subject has a current or recent history (within six months) of severe dietary or weight changes or has a history of eating disorder(s); if such has resulted in hair loss refer to exclusion criterion #5. 7. Subject has any condition which, in the investigator’s opinion, would make it unsafe for the subject to participate in this study, including clinically significant abnormal laboratory or 12-lead electrocardiogram (ECG) findings during the screening period. 8. Subject is currently enrolled in an investigational drug or device study. 9. Subject has used an investigational drug or investigational device treatment within 30 days prior to Visit 2/Baseline. 10. Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function. 11. 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. 12. Subject has a known hypersensitivity or previous allergic reaction to any of the active or inactive ingredients in the IMPs or tattoo ink. 13. Subject has used any of the following topical preparations or procedures on the scalp: ?Topical scalp treatments for hair growth including minoxidil, hormone therapy, anti-androgens, or other agents that are known to affect hair growth within 12 weeks of Visit 2/Baseline; ?Topical scalp 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. within four weeks of Visit 2/Baseline; ? Topical scalp treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to evaluate the efficacy and safety of CB-03-01 solution, 2.5%, 5.0%, 7.5% BID dosing and 7.5% QD dosing compared to vehicle for the treatment of AGA in males.;Secondary Objective: n.a.; Primary end point(s): Co-primary efficacy end points include: 1. Change from Baseline in non-vellus TAHC at Month 12. 2. HGA score at Month 12. ;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): second efficacy: 1. Change from Baseline in non-vellus TAHC at Months 3, 6, and 9. 2. HGA score at Months 3, 6, and 9. 3. Changes from Baseline in non-vellus TAHW at Months 3, 6, 9, and 12. 4. Changes from Baseline in non-vellus TAHD at Months 3, 6, 9, and 12. 5. HGI and HGSS questionnaires at Months 3, 6, 9, and 12. 6. IGA at Months 3, 6, 9, and 12. Safety endpoints include: 1. Incidence (severity and causality) of any local and systemic AEs. 2. Number of subjects with presence (and severity) of the following reactions in the LTA: erythema, scaling, pruritus, burning/stinging, skin atrophy, telangiectasia, folliculitis, hypopigmentation, and hyperpigmentation at each time point. 3. Changes from Baseline in vital signs and weight at Months 6, 12 and 13. 4. Changes from Screening in safety laboratory tests (chemistry, hematology, urinalysis and morning cortisol) at Months 6, 12 and 13. 5. Changes from Screening in overall interpretation of the ECG at Months 6, 12 and 13 (if applicable). ;Timepoint(s) of evaluation of this end point: 6, 12 and 13 months | — |
Countries
Germany
Contacts
Public ContactEnrico Fragasso
Cassiopea SpA
Outcome results
None listed