Study to assess the efficacy and safety of investigational product, P-3074 cutaneous spray, solution, in the treatment of male pattern baldness.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 450

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

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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method

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