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Study to compare the safety, tolerability and effectiveness of topical Minoxidil 5% solution in Indian male patients with mild to moderate pattern hair loss

Prospective, open label, randomized, multi-centre, study to compare the safety, tolerability and effectiveness of topical Minoxidil 5% solution (cetosomal versus conventional), in Indian male patients with mild to moderate Patterned Hair Loss(PHL)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036777
Enrollment
80
Registered
2021-09-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L649- Androgenic alopecia, unspecified

Interventions

Intervention1: Topical Minoxidil 5%: Cetosomal Minoxidil 1 ml of Minoxidil 5% solution Twice daily for 16 weeks Control Intervention1: Topical Minoxidil 5%: Conventional Minoxidil 1 ml of Minoxidil

Sponsors

Hairrevive Centre for Hair Restoration Skin Rejuvenation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Comparison of percentage change in Trichoscopy score at week 16 versus baseline in both groups 2. Comparison of proportion of patients showing improvement on Trichoscopic evaluation at week 16 versus baseline in both groups 3. Comparison of proportion of patient showing improvement in BASP grading (physician recorded) at week 16 versus baseline in both groups. 4. Comparison in proportion of patients showing improvement in clinical photographs at week 16 vs. those taken at baseline 5. Comparison of percentage improvement in mean score of Hairdex-29 scale at week 16 compared to baseline. Timepoint: upto 16 weeks

Countries

India

Contacts

Public ContactDr Sandeep Sattur

Hairrevive Centre for Hair Restoration & Skin

drsssattur@gmail.com9987355300

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026