Androgenetic alopecia MedDRA version: 20.0 Level: PT Classification code 10068168 Term: Androgenetic alopecia System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: P-3074
Product Code: P-3074
Pharmaceutical Form: Cutaneous spray, solution
INN or Proposed INN: finasteride
CAS Number: 98
Sponsors
Polichem S.A.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Written informed consent before starting any study related procedures; 2. Men 18 to 40 years of age; 3. Men with mild to moderate vertex male pattern hair loss according to a modified Norwood/Hamilton classification scale (III vertex, IV or V); 4. Patients willing to have a tattoo in the target area; 5. Outpatients; 6. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; 7. Ability to co-operate with the Investigator and to comply with the requirements of the entire study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 450 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Clinically relevant abnormal physical findings which could interfere with the aim of the study; in particular, skin damage such as abrasion, actinic keratosis or any abnormal findings in the scalp; 2. Patients who had had hair transplant surgery or hair weaving; 3. Clinically relevant abnormal laboratory values indicative of physical illness; 4. Ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study; 5. History of local infections of skin and subcutaneous tissues of the head in the 3-month period before the trial inclusion; 6. Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study; 7. Suspicion of malignancy, including prostate cancer; 8. History of infertility or difficulty fathering children; 9. Patients who wished to father children during the study or whose sexual partner(s) were pregnant; 10. Patients with active seborrheic dermatitis; 11. History of varicocele; 12. Concurrent use of systemic corticosteroids, topical corticosteroids in the balding area studied, anabolic steroids, or over-the-counter "hair restorers"; 13. Use of the following drugs with antiandrogenic properties within 6 months of study entry: flutamide, cyproterone acetate, estrogen, progesterone, cimetidine, spironolactone, or ketoconazole; 14. Patients who had been treated with any of the following drugs within the past year: minoxidil (topical or oral), zidovudine, cyclosporine, diazoxide, phenytoin, systemic interferon, psoralens, streptomycin, penicillamine, benoxaprofen, tamoxifen, phenothiazines or cytotoxic agents; 15. Use of finasteride or dutasteride within previous 12 months; 16. Light or laser treatment of scalp within previous 3 months; 17. Participation in the evaluation of any drug for 3 months before this study, calculated from the first day of the month following the last visit of the previous study; 18. History of drug, alcohol [>2 drinks/day defined according to USDA Dietary Guidelines 2010], caffeine (>5 cups coffee/tea/day) or tobacco abuse ( >=10 cigarettes/day).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether a daily treatment with P-3074 for 24 weeks increases hair count in men with male pattern baldness (MPB) compared to the vehicle.;Secondary Objective: N/A;Primary end point(s): Hair growth assessed by Target Area Hair Count (TAHC) in the vertex.;Timepoint(s) of evaluation of this end point: At 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Hair growth assessed by TAHC in the vertex at 12 Weeks; 2. Target Area Hair Width (TAHW) in the vertex at Weeks 12 and 24; 3. Patient assessment of change from baseline in Male Hair Growth Questionnaire (MHGQ) Score at Weeks 12 and 24; 4. Investigator Assessment of Improvement from Baseline to Week 12 and from Baseline to Week 24, assessed for vertex; 5. Blind Assessor Assessment of Improvement from Baseline to Week 12 and from Baseline to Week 24, assessed for vertex; 6. Assessment of sexual function at every visit (Sexual Function Index); 7. Assessment of adverse events (AEs) throughout the study; 8. Assessment of the local tolerability by means of severity scores for skin irritation; ; Timepoint(s) of evaluation of this end point: 1. At 12 Weeks 2. At Weeks 12 and 24 3. At Weeks 12 and 24 4. From Baseline to Week 12 and from Baseline to Week 24 5. From Baseline to Week 12 and from Baseline to Week 24 6. At every visit 7. Throughout the study 8. Throughout the study | — |
Countries
Belgium, Germany, Hungary, Russian Federation, Spain
Contacts
Public ContactFrancesco Scarci
Polichem S.A.
Outcome results
None listed