Topical PDT Cream Without Irradiation Source in the Acne Treatment

Not Applicable

Completed

• Conditions: Acne, Photodynamic Therapy
• Interventions: Drug: Topical application of sham control; Drug: Topical application of 1.5% Butenyl ALA

• Registration Number: NCT02313467
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2014-12-09
• Study First Posted: 2014-12-10
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• mild to moderate acne vulgaris (Leeds revised acne grading system score 2-7) at baseline.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Topical application of sham control	Topical application of sham control per every other day around acne lesions in the face
1.5% Butenyl ALA	Topical application of 1.5% Butenyl ALA	Topical application of 1.5% Butenyl ALA per every other day around acne lesions in the face

Primary Outcome Measures

Name	Time	Method
Percent change of inflammatory acne lesions compared with baseline	12 week

Secondary Outcome Measures

Name	Time	Method
Percent change of non-inflammatory acne lesions compared with baseline	12 week
Percent change of overall severity of acne lesions compared with baseline	12 week

Trial Locations

Locations (1)

Seoul National Unviersity; 🇰🇷 Seoul, Seoul Metropolitan, Korea, Republic of