Pharmacodynamics and pharmacokinetics of P-3074, a new finasteride topical solution, administered at four different doses

Completed

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

• Registration Number: ISRCTN19708972
• Lead Sponsor: Polichem SA (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-14
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

To be enrolled in this study, subjects must fulfil all of these criteria:
1. Informed consent: signed written informed consent before inclusion in the study
2. Sex and age: males, 18-65 years old 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. Body mass index: 18.5-30 kg/m2 inclusive
5. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at 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

Exclusion Criteria

Subjects meeting any of these criteria will not be enrolled in the study:
1. ECG: clinically relevant abnormalities at ECG (12 leads)
2. Skin of the scalp: skin damage such as abrasion, hyperkeratosis or any abnormal findings in the scalp
3. Physical findings: clinically relevant abnormal physical findings
4. Laboratory analysis: clinically relevant abnormal laboratory values indicative of physical illness
5. 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
6. Diseases: relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study
7. Medications: medications, including over the counter medications and herbal remedies, for 2 weeks before the start of the study (the anaesthetic used for the biopsies will be allowed; paracetamol and oral peri-operative antibiotic prophylaxis will be administered as needed)
8. Investigative drug studies: participation in the evaluation of any drug for 3 months starting from the first day of the month following the last visit in a previous study
9. Blood donations: blood donations for 3 months before this study
10. Drug, alcohol, caffeine, tobacco: 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)
11. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits within the past 4 weeks
12. Alcohol test: positive alcohol breath test before starting P-3074 administration
13. Drug abuse: positive abuse drug test at screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified