Topical PDT Cream Without Irradiation Source in the Acne Treatment

March 10, 2015 updated by: Dae Hun Suh, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seoul Metropolitan
      • Seoul, Seoul Metropolitan, Korea, Republic of, 110-744
        • Seoul National Unviersity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1.5% Butenyl ALA
Topical application of 1.5% Butenyl ALA per every other day around acne lesions in the face
Drug: Topical application of 1.5% Butenyl ALA
SHAM_COMPARATOR: Control
Topical application of sham control per every other day around acne lesions in the face
Drug: Topical application of sham control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change of inflammatory acne lesions compared with baseline
Time Frame: 12 week
12 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change of non-inflammatory acne lesions compared with baseline
Time Frame: 12 week
12 week
Percent change of overall severity of acne lesions compared with baseline
Time Frame: 12 week
12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Dae Hun Suh, MD, Seoul National University Department of Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

December 9, 2014

First Posted (ESTIMATE)

December 10, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-PDT2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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