Study to evaluate the efficacy and safety of Dutasteride Topical Solutions (0.01%, 0.02% and 0.05%) with an active comparator Finpecia (finasteride Tablets 1mg) with Androgenetic Alopecia male subjects.
- Conditions
- Health Condition 1: L649- Androgenic alopecia, unspecified
- Registration Number
- CTRI/2021/03/032173
- Lead Sponsor
- Shilpa Medicare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Male Patients 20 to 60 years of age with male pattern hair loss (Androgenetic Alopecia) according to Norwood/Hamilton classification scale (III vertex, IV and V).
2.Subjects willing to provide written informed consent, indicating that they thoroughly understand the purpose of and procedures required for the study and are willing to participate in the study.
3.Patients with no experience of treatment with Dutasteride and Finasteride from past 12 months.
4.Patients willing to have a mark in the target area.
5.Patientâ??s willingness to maintain same hair length.
6.Either partner or patient must use an effective method of contraception for avoiding pregnancy for at least 2 weeks prior to the study drug administration, during the study and up to 60 days after the last dose.
1.Clinically relevant abnormal physical findings which could interfere with the aim of the study; in particular, skin damage such as skin abrasion, actinic keratosis or any abnormal findings in the scalp.
2.Active unstable thyroid disease, including subjects on therapy for either hyperthyroidism or hypothyroidism unless their dose of thyroid medication has been stable for atleast 3 months.
3.Suspicion of malignancy, including prostate cancer.
4.Patients who had hair transplant surgery or hair weaving.
5.Patient who had light or laser treatment on the scalp.
6.History or evidence of hair loss other than Androgenetic Alopecia (e.g. due to auto-immune, endocrine, mechanical or infectious process or secondary to a scalp dermatological disorder).
7.Patients with active seborrheic dermatitis.
8.History of varicocele.
9.Clinically relevant abnormal laboratory values indicative of physical illness.
10.Ascertained or presumptive hypersensitivity to the active formulations or any of the excipients.
11.Patient with significant clinical relevant endocrinal, cerebrovascular, skin, pulmonary, haematological, immunological and cardiovascular disease could lead to safety risk.
12.History of infertility or difficulty fathering children.
13.Patients who wish to conceive children during the study or whose sexual partner is pregnant.
14.Concurrent use of systemic corticosteroids, topical corticosteroids in the balding are studied, anabolic steroids, over-the-counter.
15.Use of the following drugs with anti-androgenic properties within 6 months of study entry: flutamide, Cypoterone acetate, estrogen, progesterone. Cimetidine, spironolactone, or ketoconazole.
16.Use of any of the following medications within 14 days prior to enrolment but not limited to:
•Strong inhibitors of CYP3A4
•Strong inducers of CYP3A4
•Drugs associated with QT prolongation
•Antihypertensive and other drugs known to cause hypotension
17.Patient with known positivity for human immunodeficiency virus (HIV), HBsAg or HCV.
18.Patient had major surgery within 2 months prior to study entry, or who have not recovered from prior major surgery.
19.Patient with chronic Smokers who smokes greater than or equal to 10 cigarettes or equivalent per day.
20.Patients with intake of alcohol greater than 2 drinks or equivalent per day.
21.Patient with willing to donate blood during the study and 90 days after completion of the study.
22.Participation in a drug research study within past 3 months.
23.Any condition/ abnormal baseline findings in the laboratory values that in the Investigatorsâ?? judgment might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study e.g. expected changes in concomitant medication that may interfere in study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change in the Target Area Hair Count (Density) within 1 cm2 at the vertex as assessed by macrophotographyTimepoint: From baseline to week 24
- Secondary Outcome Measures
Name Time Method The Change in the Target Area Hair Count (Density) within 1 cm2 at the vertex from baseline to end of week 12 as assessed by macrophotographyTimepoint: Baseline to end of week 12;The Change in the Target Area Hair Count (Density) within 1 cm2 at the vertex from baseline/ week 12 to end of week 24 as assessed by macrophotographyTimepoint: From baseline/ week 12 to end of week 24;The Change in the Target Area Hair Width (Thickness) in the vertex at week 12 and end of week 24 as assessed by macrophotographyTimepoint: Week 12 to end of and 24;The investigator will assess change in hair growth from baseline to end of Week 12 and end of Week 24 in the Target Area Hair Count (Density) and Target Area Hair Width (Thickness) within 1 cm2 at the vertex, using a 7-point scale.Timepoint: Baseline to end of Week 12 and end of Week 24;The Self-administered Male Hair Growth Questionnaire (MHGQ) at week 12 and end of week 24Timepoint: Week 12 and end of week 24