Study of the safety and efficacy of topical minoxidil(5%) versus Minoxidil(5%) and Finasteride (0.1%) combination in the treatment of androgenetic alopecia in men
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Increase in hair growth
Study Overview
Brief Summary
Androgenetic alopecia is a genetically determined pattern of baldness. it causes an alteration in hair cycle dynamics that is characterised by stepwise miniaturisation of the hair follicle. This leads to vellus transformation of the terminal hair follicles. Genetic factors and androgens both play a key role in causing androgenetic hair loss. Several studies have been conducted testing the benefits of topical minoxidil and oral finasteride for the treatment of androgenetic alopecia. However, studies to prove the benefits of its combination are few in number. Hence this comparative study is undertaken. objective of the study is to compare the safety and efficacy of topical minoxidil(5%) and minoxidil(5%) +finasteride (0.1%) combination adult male patients with androgenetic alopecia and determine the various clinical patterns of androgenetic alopecia. 40 patients are enrolled in the study in which 20 patient will be treated with minoxidil(5%)(GROUP A) and other 20 will be treated with Minoxidil(5%) +Finasteride (0.1%) combination(GROUP B). Both the group will be instructed to apply 1 ml topically over the scalp. Follow up will be done every month for 4 months. Dermoscopic images of the scalp will be taken at initial visit, 8th week and 16th week. Patient will be assessed for hair growth using 5 point scale grade 1(Markedly improved), grade 2 (Moderately improved), grade 3 (slightly improved), grade 4 (unchanged), grade 5 (worsened). patient were assessed for any adverse effects of therapy at each visit.Data will be collected and analysed by frequency, percentage, Mean, standard deviation and chi-square test.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •1.Male patients between 18-45 years.
- •2.Patients with grade II –IV of modified Norwood Hamilton classification of AGA.
- •3.Men willing to use the same shampoo and maintain same hair length and colour for the entire duration of the study.
Exclusion Criteria
- •1.Patients who are not willing for the study.
- •2.Patients with dermatological disorders on the scalp other than AGA.
- •3.Patients with serious cardiovascular, renal or hepatic disease.
- •4.Patients with history of drug hypersensitivity.
- •5.Patients who are using any other therapy for AGA.
Outcomes
Primary Outcomes
Increase in hair growth
Time Frame: Increase in hair growth after and growth will be assessed at initial visit, 8th week and 16th week
Secondary Outcomes
- itching, erythema and dandruff.(To be assessed at initial visit, 8th week and 16th week)