Toxicity and Efficacy Evaluation of Topical Minoxidil in Acne Vulgaris

NCT06108193 | Unknown Phase 1 DMC

• 1 other identifier: 202001720A0
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acne Vulgaris

Keywords

androgen receptor; minoxidil

Outcome Measures

Primary Outcomes (1)

• Change from baseline systolic blood pressure

  to test the toxicity of topical minoxidil in treatment of acne vulgaris.

  Time to resolution of individual acne lesions (14 days)

Secondary Outcomes (1)

• to evaluate the response of acne treatment in this pilot study.

  Time to resolution of individual acne lesions (14 days)

Study Arms (1)

topical minoxidil in Acne Vulgaris

EXPERIMENTAL

Split face: 2% or 5% topical minoxidil solution applied and no treatment Description: Subjects will apply the 2% or 5% topical minoxidil solution to every inflammatory acne facial lesion on one half of the face and no treatment to every inflammatory acne lesion on the other half of the face twice a day for 4 weeks.

Drug: topical minoxidil in Acne Vulgaris

Interventions

topical minoxidil in Acne Vulgaris DRUG

Split face: 2% or 5% topical minoxidil solution applied and no treatment Description: Subjects will apply the 2% or 5% topical minoxidil solution to every inflammatory acne facial lesion on one half of the face and no treatment to every inflammatory acne lesion on the other half of the face twice a day for 4 weeks.

topical minoxidil in Acne Vulgaris

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Gender: both
• Age limit: 20\~50 year/old
• Acne vulgaris: mild to moderate degree (Investigator's Global Assessment Scale:2\~3)

You may not qualify if:

• pregnant or breast feeding woman
• allergic to minoxidil or any ingredient of minoxidil solution including alcohol and propylene glycol
• deny to discontinue topical therapy of acne more than 7 days before starting treatment
• deny to discontinue systemic therapy of acne more than 28 days before starting treatment
• alopecia under or ever using minoxidil, known androgen-AR pathway blocker
• using shampoo containing minoxidil component in 28 days before starting treatment
• irregular menstruation of known case of polycystic ovarian syndrome
• Have had a facial procedure 2 weeks before the study start
• using any oral contraceptives that have a specific anti-androgenic action 12 weeks before the study start

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris; Bulbo-Spinal Atrophy, X-Linked

Interventions

Minoxidil

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Muscular Atrophy, Spinal; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Motor Neuron Disease; Neuromuscular Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Cheng-Lung Hsu, Profesor

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng-Lung Hsu, Profesor

CONTACT

(886)33281200; hsu2221@cgmh.org.tw

He-Cing Fan

CONTACT

(886)33281200; r94b47405@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: PBF Minoxidil Solution 5% PBF Minoxidil Solution 2% Split face: 2% or 5% topical minoxidil solution applied and no treatment Description: Subjects will apply the 2% or 5% topical minoxidil solution to every inflammatory acne facial lesion on one half of the face and no treatment to every inflammatory acne lesion on the other half of the face twice a day for 4 weeks.

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: October 30, 2023
• Study Start: July 11, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 3, 2023

Record last verified: 2023-11

Locations

TW (1)