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 range21 Years ā 65 Years
SexMALE
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Inclusion criteria
ā. Males ages 21-65 years old with MPHL
ā. Norwood III vertex-V. The vertex scalp must be involved
ā. MPHL diagnosed by a board-certified dermatologist
ā. Willing to abstain from use of over the counter products and prescription products other than those supplied in the study
ā. Willing to abstain from the use of non-steroidal anti-inflammatory medications, aspirin, St. Johns Wart, and high doses of Vitamin E supplementation
ā. Subjects must be capable of giving informed consent
ā. Willing to adhere to protocol, including scalp examinations and photography
Exclusion criteria
ā. Allergy or intolerance to minoxidil
ā. Underlying disease that might be adversely affected by minoxidil.
ā. Immunosuppressed patients (history of transplantation, cancer, chemotherapy, splenectomy, HIV)
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
ā. Application of topical immunomodulatory or immunosuppressive agent in the preceding 6 weeks
ā. 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
ā. Clinical evidence of secondary skin infection (e.g. folliculitis)
ā. Other inflammatory or infectious skin disease that might interfere with evaluations during the study
ā. Investigational medications within the past 30 days