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Evaluating the safety and effectiveness of minoxidil (5%) with procapil, redensyl, caffeine & transcutol vs plain minoxidil (5%) in androgenetic alopecia

An open-label prospective multicentric real-world evidence study to evaluate the safety and effectiveness of minoxidil (5%) with a combination of procapil, redensyl, caffeine, and transcutol vs plain minoxidil (5%) topical solution in study subjects with androgenetic alopecia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN65325698
Enrollment
500
Registered
2024-12-10
Start date
2023-09-15
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Androgenetic alopecia (AGA) Skin and Connective Tissue Diseases

Interventions

Participants were assigned to treatment groups at the discretion of the treating physicians. It was determined based on clinical judgment and patient suitability for the interventions. Intervention A

Sponsors

Zydus Healthcare Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male or female participants aged 18 years and above 2. Participants with a confirmed diagnosis of Androgenetic Alopecia (AGA) 3. Participants eligible to receive topical Minoxidil 5% solutions for the treatment of AGA at the discretion of the treating physician 4. Participants willing to provide written informed consent 5. Participants who have not received any topical or systemic treatment for hair loss prior to enrollment in the study

Exclusion criteria

Exclusion criteria: 1. Participants with known hypersensitivity to Minoxidil or any of the ingredients in the test products (MpowerTM or plain minoxidil) 2. Pregnant or breastfeeding females or those planning a pregnancy during the study period 3. Participants with any medical condition that contraindicates the use of minoxidil as determined by the treating physician 4. Participants currently using any other topical or systemic treatments for hair loss 5. Participants with scalp conditions such as inflammation, erythema, infection, irritation, or pain at the application site

Design outcomes

Primary

MeasureTime frame
1. Hair diameter measured using trichoscopic analysis at baseline, 2 and 4 months 2. Terminal hair density evaluated through trichoscopic analysis at baseline, 2 and 4 months (measured in hairs/cm²) 3. Total hair density: assessed via trichoscopy at baseline, 2 and 4 months (measured in hairs/cm²) 4. Vellus hair percentage measured using trichoscopy at baseline, 2 and 4 months

Secondary

MeasureTime frame
1. Subject satisfaction assessed using the Subject Satisfaction Questionnaire (SSQ) at the end of 4 months 2. Tolerability evaluated based on investigator and participant feedback at 4 months using a four-point scale (excellent, good, fair, poor) 3. Compliance calculated from daily entries in participant diaries, reviewed at 2 and 4 months

Countries

India

Contacts

Public ContactPrachi Sharma
patientsafety@tatvacare.in+91 (0)8290799906

Outcome results

None listed

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