Overview

This trial is active, not recruiting.

Condition acne, photodynamic therapy
Treatments topical application of 1.5% butenyl ala, topical application of sham control
Sponsor Seoul National University Hospital
Start date December 2014
End date April 2015
Trial size 44 participants
Trial identifier NCT02313467, SNUH-PDT2

Summary

In this study, the investigators are going to compare the clinical effect and safety of topical application of 1.5% Butenyl ALA cream formula without light source irradiation in the treatment of acne.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Topical application of 1.5% Butenyl ALA per every other day around acne lesions in the face
topical application of 1.5% butenyl ala
(Sham Comparator)
Topical application of sham control per every other day around acne lesions in the face
topical application of sham control

Primary Outcomes

Measure
Percent change of inflammatory acne lesions compared with baseline
time frame: 12 week

Secondary Outcomes

Measure
Percent change of non-inflammatory acne lesions compared with baseline
time frame: 12 week
Percent change of overall severity of acne lesions compared with baseline
time frame: 12 week

Eligibility Criteria

Male or female participants from 19 years up to 45 years old.

Inclusion Criteria: - mild to moderate acne vulgaris (Leeds revised acne grading system score 2-7) at baseline. Exclusion Criteria: - known pregnancy - lactation - any medical illness that might influence the results of the study - a history of oral acne medication or surgical procedure, including laser treatment, within 6 months of study enrollment - use of topical acne medication within 4 weeks of study enrollment.

Additional Information

Official title Topical Application of 1.5% Butenyl ALA Without Light Source Irradiation in the Treatment of Acne: a Double Blinded Randomized Controlled Trial.
Principal investigator Dae Hun Suh, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.