Health Condition 1: L649- Androgenic alopecia, unspecified
Conditions
Interventions
Intervention1: Dutasteride Topical Solution (0.05%): 1 ml solution once daily at evening for 6months treatment one month regression and again 3 months for only test group
Control Intervention1: Fenast
Sponsors
Shilpa Medicare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male patients of 20 to 55 years of age with male pattern hair loss Androgenetic Alopecia according to NorwoodHamilton classification scale III 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 Patients 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
Exclusion criteria
Exclusion criteria: 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 at least 3 months 3 History Suspicion of malignancy including prostate cancer within five years 4 Subjects who had hair transplant surgery or hair weaving 5 Subject who had light or laser treatment on the scalp 6 History or evidence of hair loss other than Androgenetic Alopecia eg due to auto immune endocrine mechanical or infectious process or secondary to a scalp dermatological disorder 7 Subjects 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 Subject with significant clinically relevant endocrinal, cerebrovascular skin pulmonary haematological immunological and cardiovascular disease could lead to safety risk 12 History of infertility or difficulty fathering children 13 Subjects who wish to conceive children during the study or whose sexual partner is pregnant 14 Concurrent use of systemic corticosteroids topical corticosteroids 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 Subject with known positivity for human immunodeficiency virus HIV HBsAg or HCV 18 Subject had major surgery within 2 months prior to study entry or who have not recovered from prior major surgery 19 Chronic smoking who smokes greater than or equal to 10 cigarettes or equivalent per day 20 Subjects with intake of alcohol greater than 2 drinks or equivalent per day 21 Subject likely 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 Investigators judgment might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study eg expected changes in concomitant medication that may interfere in study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the Target Area Hair Count (Density) within 1 cm2 at the vertex from baseline to end of week 24 as assessed by macrophotography.Timepoint: baseline to end of week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in Hair thinning to end of week 12 and week 24 and from end of week 12 to end of week 24 using Norwood scale.Timepoint: end of week 12 and week 24 & from end of week 12 to end of week 24;Reduction in hair thinning to end of week 12 and week 24 and from end of week 12 to end of week 24 using standard photo-numerical scale (1-10)Timepoint: end of week 12 and week 24 & from end of week 12 to end of week 24;Change from baseline in hair growth rate at end of week 12 and week 24 using TrichoScan .Timepoint: at end of week 12 and week 24;Change from baseline in hair density (count/cm2) at the end of week 12 and change from end of week 12 to end of week 24 using TrichoScan .Timepoint: at the end of week 12 & from end of week 12 to end of week 24;Change from baseline in hair thickness to end of week 12 and week 24 and from end of week 12 to end of week 24 using Dino-Lite.Timepoint: end of week 12 and week 24 & from end of week 12 to end of week 24;Change from baseline in Anagen/ Telogen (A:T) ratio to end of week 12 and week 24 using TrichoScan .Timepoint: end of week 12 and week 24;Change from baseline for improvement in density (count/cm2) of terminal and vellus hair to end of week 12 and week 24 using TrichoScan .Timepoint: end of week 12 and week 24;Change in hair growth using 7 pointer dermatological scale (CGI- C) (-3 = greatly decreased, -2= moderately decreased, -1= slightly decreased, 0= no change, +1= slightly increased, +2= moderately increased and +3 = greatly increased) in comparison to baseline, end of week 12 and end of week 24- global photography.Timepoint: end of week 12 and week 24;Change from baseline for improvement in hair growth in accordance to self- administered Male Hair Growth Questionnaire (MHGQ) to the end of week 12 and week 24.Timepoint: end of week 12 and week 24;Change From Baseline in Hair Growth Index (HGI) Scores at Weeks 12 and 24.Timepoint: at weeks 12 and 24.;Change From Baseline in Total Hair Growth Satisfaction Scale (H | — |
Countries
India
Contacts
Public ContactDr P Veerendrakumar
Shilpa Medicare Ltd.
Outcome results
None listed