Pharmacokinetics of two different formulations of finasteride (topical and oral) in male volunteers with androgeneic alopecia

Completed

• Conditions: Androgeneic alopecia; Skin and Connective Tissue Diseases; Androgenic alopecia, unspecified

• Registration Number: ISRCTN64760291
• Lead Sponsor: Polichem S.A. (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-08
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

1. Sex: male
2. Age: 18-65 year-old inclusive
3. Androgeneic 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. Body Mass Index (BMI): 18 < BMI < 30 kg/m2;
5. Vital signs: Systolic Blood Pressure (SBP) 100-139 mmHg, Diastolic Blood Pressure (DBP) 50-89 mmHg, Heart Rate (HR) 50-90 bpm, measured after 5 min of rest in the sitting position
6. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; 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. Electrocardiogram (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