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Topical PDT Cream Without Irradiation Source in the Acne Treatment

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne, Photodynamic Therapy

Intervention: Topical application of 1.5% Butenyl ALA (Drug); Topical application of sham control (Drug)

Phase: N/A

Status: Completed

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Dae Hun Suh, MD, Principal Investigator, Affiliation: Seoul National University Department of Dermatology

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.

Clinical Details

Official title: Topical Application of 1.5% Butenyl ALA Without Light Source Irradiation in the Treatment of Acne: a Double Blinded Randomized Controlled Trial.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percent change of inflammatory acne lesions compared with baseline

Secondary outcome:

Percent change of non-inflammatory acne lesions compared with baseline

Percent change of overall severity of acne lesions compared with baseline

Eligibility

Minimum age: 19 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Seoul National Unviersity, Seoul, Seoul Metropolitan 110-744, Korea, Republic of
Additional Information

Starting date: January 2014
Last updated: March 10, 2015

Page last updated: August 23, 2015

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