Overview

Toxicity and Efficacy Evaluation of Topical Minoxidil in Acne Vulgaris

Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
0
Participant gender:
All
Summary
Patients with acne vulgaris (AV) appeared to be a chronic inflammation with a wide range in teenagers and adult. The protocol design is as follows. The subjects enrolled through inclusion and exclusion criteria will undergo the blood and urine biochemical tests for baseline record. The photos from the subjects will be recorded per day, and the blood and urine biochemical tests will be recorded per week. Objectives: primary: to test the toxicity of topical minoxidil in treatment of acne vulgaris; second: to evaluate the response and disease control rate in this pilot study. Measurement: Time to resolution of individual acne lesions (14 days) Monitor of treatment efficacy: number of inflammatory acne lesions counting, time to resolution of individual acne lesion, and degree of acne severity measurement.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chang Gung Memorial Hospital
Treatments:
Minoxidil
Criteria
Inclusion Criteria:

1. Gender: both

2. Age limit: 20~50 year/old

3. Acne vulgaris: mild to moderate degree (Investigator's Global Assessment Scale:2~3)

Exclusion Criteria:

1. pregnant or breast feeding woman

2. allergic to minoxidil or any ingredient of minoxidil solution including alcohol and
propylene glycol

3. deny to discontinue topical therapy of acne more than 7 days before starting treatment

4. deny to discontinue systemic therapy of acne more than 28 days before starting
treatment

5. alopecia under or ever using minoxidil, known androgen-AR pathway blocker

6. using shampoo containing minoxidil component in 28 days before starting treatment

7. irregular menstruation of known case of polycystic ovarian syndrome

8. Have had a facial procedure 2 weeks before the study start

9. using any oral contraceptives that have a specific anti-androgenic action 12 weeks
before the study start