A Randomised Study to Evaluate the Efficacy and Adverse Effects of Oral Minoxidil and Oral Dutasteride in Androgenetic Alopecia

INTRODUCTION:

Androgenetic alopecia (AGA) is common form of patterned hair loss on the scalp affecting males. There is a gradual decline in the production of hair that may eventually lead to balding. Topical minoxidil and oral finasteride are the only FDA approved drugs for treatment of AGA. Oral minoxidil and oral dutasteride are promising new drugs which may be used in AGA. In this background, the present study is being undertaken to evaluate and confirm and compare the efficacy and adverse effects of oral minoxidil and oral dutasteride in treatment of androgenetic alopecia. Hence the present study has been undertaken.

A paired student’s t- test will be utilised to compare means before and after the treatment, while a student’s unpaired t-test will be employed to compare means between different procedures. For all statistical analysis, P value <0.05 will be considered as statistically significant.

 AIM AND OBJECTIVES:

To study the efficacy and adverse effects of oral minoxidil and oral dutasteride in androgenetic alopecia.

MATERIALS AND METHODOLOGY:

Detailed history will be taken and thorough dermatological examination will be performed.

After the diagnosis of Androgenetic alopecia is established, All the patients will be subjected to certain blood tests like Hemogram, viral markers and RBS.

The stage of male pattern baldness will be determined using Modified Norwood Hamilton classification.

A Baseline Macrophotograph of mid-anterior scalp will be taken. A 1cm2 area will be marked and number of hairs within the given area will be counted to know the density of hair.

Photographs are also taken by a Dermoscopy device connected to cell phone at a distance of 16cm from the glabella. The thickness of five randomly selected hairs in close proximity will be measured using 3D slicer 5.8.1 software and then averaged.

After obtaining an informed consent, patients will be distributed into 2 groups A and B via randomization sequence provided by statistician.

Group A will be treated with oral minoxidil 2.5 mg OD and group B will be treated with oral dutasteride 0.5 mg OD .

All patients will be followed every month for 6 months. Macroscopic Serial photographs, dermoscopic images will be taken each month of follow up to measure hair density and thickness.

Adverse effects are enquired each month, if any will be noted.

After 6 months, Final assessment of response to treatment will be done by comparing hair thickness and density with baseline values.

Macro-Photographs will be assessed using a standardized 7-point rating scale to evaluate hair growth compared to baseline.

Patient satisfaction will be assessed using patient satisfaction score, while physician will assess the improvement via visual analogue scale and will be compared with baseline.