Study of two different formulations of finasteride in male volunteers with androgenetic alopecia

Not Applicable

Completed

• Conditions: Androgenetic alopecia; Skin and Connective Tissue Diseases; Androgenic alopecia

• Registration Number: ISRCTN98903916
• Lead Sponsor: Polichem S.A. (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-08
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

1. Sex - male
2. Age: 18-65 year olds inclusive
3. Androgenetic alopecia: recession of the frontal hairline and hair loss in the vertex or crown or loss of hair over the frontal and vertex scalp regions, corresponding to at least stage 2 of the Hamilton-Norwood scale
4. BMI: 18, TBMI, T30 kg/m2
5. Vital signs: SBP 100-139 mmHg, DBP 50-89 mmHg, HR 50-90 bpm, measured after 5 min of rest in the sitting position
6. Full comprehension:
6.1. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects
6.2. Ability to co-operate with the Investigator and to comply with the requirements of the entire study
7. Informed consent: signed written informed consent prior to inclusion in the study

Exclusion Criteria

1. ECG (12-leads) (supine position): clinically relevant abnormalities
2. Physical findings: clinically relevant abnormal physical findings which could interfere with the objectives of the study; in particular, skin damage such as abrasion, hyperkeratosis or any abnormal findings in the scalp
3. Laboratory analyses: clinically relevant abnormal laboratory values indicative of physical illness
4. Allergy: 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. Diseases: relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study
6. Medications: medications, including over the counter (OTC) drugs, for 2 weeks before the start of the study
7. Investigative drug trials: 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
8. Blood donation: blood donations for 3 months before this study
9. Drug, alcohol, caffeine, tobacco: history of drug, alcohol [>2 drinks/day], caffeine (>5 cups coffee/tea/day) or tobacco abuse (<10 cigarettes/day)
10. Abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum and scalp concentration of testosterone and dihydrotestosterone before and after multiple dose administration of topical or oral finasteride formulation

Secondary Outcome Measures

Name	Time	Method
1. Adverse events<br>2. Vital signs (blood pressure, heart rate)<br>3. Electrocardiogram <br>4. Physical examination<br>5. Laboratory parameters