Study to compare the safety, tolerability and effectiveness of topical Minoxidil 5% solution in Indian male patients with mild to moderate pattern hair loss
- Conditions
- Health Condition 1: L649- Androgenic alopecia, unspecified
- Registration Number
- CTRI/2021/09/036777
- Lead Sponsor
- Hairrevive Centre for Hair Restoration Skin Rejuvenation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Adult male patients of PHL of mild-moderate severity (BASP grading)
Patients willing to refrain from other forms of treatment including other topical, oral medication for hair loss, laser treatments, injectable treatments and hair transplantation for the duration of study
Patients who are willing to appear for regular follow ups and follow the prescribed treatment regularly
Patients who are willing to give consent to participate in the study
1.Patients suffering from other causes of non-cicatricial alopecia or cicatricial alopecia.
2.Patients suffering from infectious, auto-immune, or other disorders affecting skin of scalp.
3.Patients suffering from severe PHL, BASP scale M3, C2, C3, U1, U2, U3, V2, V3, F2, and F3 were recorded as â??severeâ?? and excluded from the study.
4.Documented and known history of severe systemic disease, necessitating medical treatment, as assessed by the Investigator that might interfere with the conduct of the study or the interpretation of results.
5.Patients known to be allergic to the any of the components of the study medications.
6.Patients who are receiving drugs which are known to affect hair growth.
7.Patients with known malignancy.
8.Refusal to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison in proportion of patients showing one or more adverse effects or change in the parameters of local skin tolerability (erythema, dryness, hyperpigmentation, skin peeling, pruritus) from baseline, with Cetosomal vs. Conventional Minoxidil 5% solutionTimepoint: upto 16 weeks
- Secondary Outcome Measures
Name Time Method 1.Comparison of percentage change in Trichoscopy score at week 16 versus baseline in both groups <br/ ><br>2.Comparison of proportion of patients showing improvement on Trichoscopic evaluation at week 16 versus baseline in both groups <br/ ><br>3.Comparison of proportion of patient showing improvement in BASP grading (physician recorded) at week 16 versus baseline in both groups. <br/ ><br>4.Comparison in proportion of patients showing improvement in clinical photographs at week 16 vs. those taken at baseline <br/ ><br>5.Comparison of percentage improvement in mean score of Hairdex-29 scale at week 16 compared to baseline. <br/ ><br>Timepoint: upto 16 weeks