Topical PDT Cream Without Irradiation Source in the Acne Treatment

Acne, Photodynamic Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02313467
• Other study ID #: SNUH-PDT2
• Status: Completed
• Phase: N/A
• First received: December 8, 2014
• Last updated: March 10, 2015
• Start date: January 2014
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: KFDA : Korea
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 45 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Acne, Photodynamic Therapy

Intervention

Drug:
• Topical application of 1.5% Butenyl ALA

• Topical application of sham control

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Unviersity	Seoul	Seoul Metropolitan

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change of inflammatory acne lesions compared with baseline		12 week	No
Secondary	Percent change of non-inflammatory acne lesions compared with baseline		12 week	No
Secondary	Percent change of overall severity of acne lesions compared with baseline		12 week	No