Evaluating the safety and effectiveness of minoxidil (5%) with procapil, redensyl, caffeine & transcutol vs plain minoxidil (5%) in androgenetic alopecia
| ISRCTN | ISRCTN65325698 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65325698 |
| Secondary identifying numbers | Protocol No. TV/03/09/23 |
- Submission date
- 04/12/2024
- Registration date
- 10/12/2024
- Last edited
- 06/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
Background and study aims
Androgenetic alopecia (AGA) is a common hair loss condition affecting men and women, impacting confidence and quality of life. This study compares two treatments: plain 5% minoxidil and MpowerTM (5% minoxidil with procapil, redensyl, caffeine, and transcutol). The aim is to assess which treatment is more effective and safe for improving hair growth.
Who can participate?
Adults aged 18 years and above with AGA who have not used other hair loss treatments
What does the study involve?
Participants will be randomly allocated to apply either MpowerTM or plain 5% Minoxidil to their scalp for 4 months. Men will apply it twice daily, and women once at night. Assessments will take place at baseline, 2 and 4 months, including hair growth measurements and satisfaction surveys.
What are the possible benefits and risks of participating?
Participants may experience an improvement in hair growth. Risks include mild side effects like scalp dryness or irritation, which will be monitored.
Where is the study run from?
Zydus Healthcare Limited (India)
When is the study starting and how long is it expected to run for?
September 2023 to October 2024
Who is funding the study?
Zydus Healthcare Limited (India)
Who is the main contact?
Dr Monika Chinda, monika.chinda@zyduslife.com
Contact information
Public, Scientific
Digicare Healthcare Solutions Private Limited
Ahmedabad
380058
India
| Phone | +91 (0)8290799906 |
|---|---|
| patientsafety@tatvacare.in |
Principal Investigator
Angel skin hair laser clinic, New Ranip
Ahmedabad
382480
India
| Phone | +91 (0)9099040705 |
|---|---|
| angelskinclinic@gmail.com |
Study information
| Study design | Open-label prospective multicentric real-world evidence study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice, Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | 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 |
| Study hypothesis | MpowerTM (5% minoxidil with procapil, redensyl, caffeine, and transcutol) is more effective and safer than plain 5% minoxidil in improving hair parameters (diameter, vellus hair percentage, terminal and total hair density), patient satisfaction, tolerability, and compliance in patients with androgenetic alopecia. |
| Ethics approval(s) |
Approved 14/09/2023, ACEAS-Independent Ethics Committee (Aradhya, Ambawadi, Ahmedabad, 380015, India; +91 (0)7926460930; iecaceas@gmail.com), ref: Protocol # TV/03/09/23 |
| Condition | Androgenetic alopecia (AGA) |
| Intervention | 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 Arm: Participants in this group will receive MpowerTM, a topical solution containing 5% Minoxidil combined with Procapil, Redensyl, Caffeine, and Transcutol. Comparator Arm: Participants in this group will receive plain 5% Minoxidil topical solution. Participants will be randomly allocated to apply either MpowerTM or plain 5% Minoxidil to their scalp for 4 months. Men will apply it twice daily, and women once at night. Assessments will take place at baseline, 2 and 4 months, including hair growth measurements and satisfaction surveys. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | MPowerTM (5% minoxidil with procapil, redensyl, caffeine, and transcutol), plain minoxidil (5% minoxidil solution) |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 14/09/2023 |
| Overall study end date | 11/10/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 500 |
| Total final enrolment | 400 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 15/09/2023 |
| Recruitment end date | 11/06/2024 |
Locations
Countries of recruitment
- India
Study participating centres
India
India
India
India
India
India
India
India
India
India
India
India
India
India
Sponsor information
Industry
Zydus Tower CTS No- 460/6 of Village Pahadi
Off I. B. Patel Road
Goregaon (East)
Mumbai
400063
India
| Phone | +91 (0)9920810337 |
|---|---|
| Monika.Chinda@zyduslife.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 11/10/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | The data from this study are not expected to be made available. This decision is based on the proprietary nature of the research, the study data captured is deidentified data coalited through electronic data capture in the clinical trial management system. |
Editorial Notes
04/12/2024: Study's existence confirmed by ACEAS-Independent Ethics Committee.
