Topical treatment regimens in male androgenetic alopecia

Completed

Brief Summary: Androgenetic alopecia (AGA) is the most common cause of hair loss in males and females and is characterized by a patterned hair loss. It can be psychosocially and emotionally very distressing to the patient leading him/her to feel unattractive and less confident. It has been therapeutically challenging to treat this condition. There are very limited atudies which have documented the efficacy of various treatment options. Therefore, this study aims to observe the efficacy of three topical treatment regimens that are routinely offered to patients with AGA presenting to our hospital, so as to identify the most effective treatment regimen available for these patients.

This is an open label randomized controlled trial where patients will be randomized by computer generated variable block size randomization. Patients will be allocated into three groups by sealed opaque envelope technique. Follow up period is 6 months and patients will be assessed at 12 and 24 weeks and the following observations will be made:

1. Mean physician assessment score (PAS)

2. Mean change in hair density

3. Mean change in number of terminal and vellus hair

4. Mean patient satisfaction score (PSS)

5. Proportion of patients experiencing side effects

Data will be collected and compiled in an excel sheet and will be analyzed statistically.

Recruitment & Eligibility

Inclusion Criteria

All new male patients with clinically diagnosed androgenetic alopecia of grade III or higher (Modified Norwood Hamilton classification).

Exclusion Criteria

Patients who have used any topical or systemic drugs in the past 6 months to promote hair growth 2.
Patients with other scalp diseases that affect hair growth including seborrheic capitis 3.
Patients with elevated levels of serum prostate specific antigen (PSA) 4.
Patients with thyroid abnormality or vitamin D deficiency 5.
Patients with history of continuing intake of following drugs â€“ antihypertensives, antiepileptics, cytotoxic drugs, systemic corticosteroids, bronchodilators and vasodilators.

Primary Outcome Measures

Name	Time	Method
Improvement in one or more of the following parameters in the three groups:	12 and 24 weeks
1. Mean Physician Assessment score (PAS)	12 and 24 weeks
2. Mean change in hair density from baseline	12 and 24 weeks
3. Mean change in number of terminal and vellus hair from baseline	12 and 24 weeks

Secondary Outcome Measures

Name	Time	Method
Mean Patient Satisfaction Scores (PSS)	12 and 24 weeks
Proportion of patients experiencing side effects in the three groups	12 and 24 weeks

Locations (1): Lady Hardinge Medical College
🇮🇳
Delhi, DELHI, India
Lady Hardinge Medical College
🇮🇳Delhi, DELHI, India
Dr Apoorva V Bharadwaj
Principal investigator
9686257492
avb185@gmail.com