Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia (NCT03852992) | Clinical Trial Compass
WithdrawnPhase 2
Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia
Stopped: Study was closed with IRB on 10/22/22
United States0Started 2022-09-30
Plain-language summary
The objective of this study is to evaluate the safety and efficacy of fractionated ablative 10,600nm CO2 laser assisted delivery of 2% minoxidil solution in the treatment of MPHL. In this cohort study, patients will randomly be assigned stand-alone laser treatment, laser assisted drug delivery of minoxidil 2% solution, and laser assisted drug delivery of minoxidil 2% solution plus at home 5% minoxidil treatment. The primary endpoints will be to assess the change from baseline in investigator and subject Hair Growth Assessments (HGA), Hair Growth Index (HGI) and the Hair Growth Satisfaction Scale (HGSS) over 8-12 weeks in each of the three groups. The secondary endpoints will be expert assessment of hair density from baseline and evaluation of safety and adverse events, and pharmacokinetic (PK) data.
Who can participate
Age range
21 Years – 65 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males ages 21-65 years old with MPHL
. Norwood III vertex-V. The vertex scalp must be involved
. MPHL diagnosed by a board-certified dermatologist
. Willing to abstain from use of over the counter products and prescription products other than those supplied in the study
. Willing to abstain from the use of non-steroidal anti-inflammatory medications, aspirin, St. Johns Wart, and high doses of Vitamin E supplementation
. Subjects must be capable of giving informed consent
. Willing to adhere to protocol, including scalp examinations and photography
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hair Growth Assessment (HGA)
Timeframe: End of trial (8-16 weeks)
2
Hair Growth Index (HGI)
Timeframe: End of trial (8-16 weeks)
3
Change in Hair Growth Satisfaction Scale (HGSS)
Timeframe: Week 0, Week 4(+4), Week 8(+4)
4
Change in Investigator Global Assessment of Photography
. Underlying disease that might be adversely affected by minoxidil.
. Immunosuppressed patients (history of transplantation, cancer, chemotherapy, splenectomy, HIV)
. Application of topical immunomodulatory or immunosuppressive agent in the preceding 6 weeks
. Systemic administration of corticosteroid or other systemic treatment (e.g. prednisone) that has immunomodulatory or other immunosuppressive mechanism of action, in the preceding 8 weeks or planned usage at any time throughout the study
. Clinical evidence of secondary skin infection (e.g. folliculitis)
. Other inflammatory or infectious skin disease that might interfere with evaluations during the study
. Investigational medications within the past 30 days