Female Androgenic Alopecia (AGA) 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 Anti-androgens may be an effective treatment for AGA. MedDRA ver
Conditions
Interventions
Product Name: Cortexolone 17a-propionate solution 5%
Product Code: CB-03-01 solution 5%
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Cortexolone 17a-propionate
CAS Number: 19608-29-8
Sponsors
Cassiopea S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subject is female, 18-55 years old. 2.Subject has provided written informed consent. 3.Negative pregnancy test at screening and baseline for women of childbearing potential (WOCBP) 4.Exhibits AGA based on a discernable decrease in hair density on the top of the scalp, relative to the sides and back of the scalp, with scalp hair density in involved density area stages n. 3 to n. 6 on the Savin Density Scale. 5.Subject is willing to maintain the same hairstyle, hair length, and hair color throughout the study (implying the same hair coloring interval prior to the approved photos at screening/baseline) 6.Subject is willing to comply with study instructions and return to the clinic for required visits. 7.Subject agrees to continue her other general hair care products and regimen for the entire study. 8.Subject agrees to maintain same dietary and supplement pattern. 9. If subjects is sexually active with a male partner and is not surgically sterile or postmenopausal she must agree to use an acceptable form of birth control throughout the study and at least for one month after the end of treatment, as described in the informed consent form. An acceptable method (Pearl Index =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Pregnancy or planned pregnancy 2. Breastfeeding women 3. 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. 4. Subject has any skin pathology or condition that, in the investigator’s opinion, could interfere with the evaluation of IMP or requires use of interfering topical, systemic, or surgical therapy. 5. Subject has a history or any signs of hyperandrogenemia 6. Subject has current/recent history (within 6 months) of hair weaves, non-breathable wigs, or hair bonding. 7. Subject had scalp hair transplants at any time 8. Subject has a history or active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/diseases other than AGA 9. Subject has a current or recent history (within 6 months) of severe dietary or weight changes or has a history of eating disorder(s) any history of bariatric surgery (gastric bypass, gastric sleeve, stomach stapling); macro- or micro-nutrient deficiencies within the last 6 months (i.e.: clinically significant iron deficiency, protein deficiency confirmed by lab testing) and/or any current diagnosis of malabsorptive disease (i.e Celiac, Irritable Bowel disease etc). 10. 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 findings during the screening period 11. Subject with diagnosed treated or untreated hypertension and/ or with signs of or known clinically significant cardiovascular diseases or cardiac arrhythmia 12. Subject is currently enrolled in an investigational drug or device study 13. Subject has used an investigational drug or investigational device treatment within 30 days or 5 half-lives (whichever is longer)prior to Visit 2/Baseline. 14. Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function. 15. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, subjects who are unable to return for scheduled follow-up visits, or subjects who are institutionalized because of legal or regulatory order 16. Subject has a known hypersensitivity or previous allergic reaction to any of the active or inactive ingredients in the IMPs or tattoo ink 17. Subject has used any of the following topical preparations or procedures on the scalp: a) Topical scalp treatments for hair growth or other agents known to affect hair growth within 12weeks of Visit 2/Baseline; b) Topical scalp over-the-counter or cosmetic treatments known or reasonably believed to affect hair growth/health or hair growth products with saw palmetto, copper, etc. within 4weeks of Visit 2/Baseline c) Topical scalp treatments that may have ancillary effect on hair growth (e.g.corticosteroids, retinoids) within 4weeks of Visit 2/Baseline d) Scalp procedures within 6 months of Visit 2/Baseline; e) Platelet rich plasma (PRP) procedure on the scalp within 1 year 18. Subject has used the following systemic medications/procedures: a) Beta blockers, cimetidine, diazoxide, or corticosteroids within 12 weeks of Visit 2/Baseline. Inha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: NA;Primary end point(s): Co-primary efficacy endpoints include: 1.CB-03-01 Treatment Effects in Change from Baseline in non-vellus TAHC at Month 6 in Comparison to Vehicle. 2.CB-03-01 Treatment Effects in HGA score at Month 6 in Comparison to Vehicle.;Timepoint(s) of evaluation of this end point: months 6 (both co-primary endpoints);Main Objective: The objective of this study is to evaluate the efficacy and safety of CB-03-01 solution 5%, 7.5% BID dosing compared to the Minoxidil solution 2% (BID) and the vehicle solution (BID) for the treatment of androgenetic alopecia in females. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: 1.CB-03-01 Treatment Effects in Changes from Baseline in non-vellus TAHC at Months 3 in Comparison to Vehicle 2.CB-03-01 Treatment Effects in HGA score at Months 3 in Comparison to vehicle. 3.CB-03-01 Treatment Effects in Changes from Baseline in non-vellus TAHC at Months 3 and 6 in Comparison to Minoxidil 4. CB-03-01 Treatment Effects in HGA score at Months 3 and 6 in Comparison to Minoxidil. 5.CB-03-01 Treatment Effects in Changes from Baseline in non-vellus TAHW at Months 3 and 6 in Comparison to Vehicle and Minoxidil, respectively. 6.CB-03-01 Treatment Effects in Changes from Baseline in non-vellus TAHD at Months 3 and 6 in Comparison to Vehicle and Minoxidil, respectively. 7. CB-03-01 Treatment Effects in HGI and HGSS scores at Months 3 and 6 in Comparison to Vehicle and Minoxidil, respectively. 8. CB-03-01 Treatment Effects in IGA at Months 3 and 6 in Comparison to Vehicle and Minoxidil, respectively Cosmetic Evaluation: 1.Acceptability score 2.Easy to use score Safety: 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.Number of subjects with presence (and severity) of Facial hypertrichosis 4.Changes from Baseline in vital signs and weight 5.Changes from Screening in overall interpretation of the ECG at Month 3, 6 and 7 (if applicable) 5.Changes from Screening in safety laboratory tests (chemistry, hematology, urinalysis, and morning cortisol) 6.Changes from Screening in overall interpretation of the ECG PK Analysis: Trough concentrations of CB-03-01 ;Timepoint(s) of evaluation of this end point: Efficacy: 1 Months 3 2 Month 3 3 Months 3+6 4 Months 3+6 5 Months 3 + 6 6 Months 3 + 6 7 Months 3 + 6 8 Months 3 + 6 Cosmetic Evalua | — |
Countries
Germany
Contacts
Public ContactCRO /Clinical Trial Management
bioskin GmbH
Outcome results
None listed