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Topical PDT Cream Without Irradiation Source in the Acne Treatment

Primary Purpose

Acne, Photodynamic Therapy

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Topical application of 1.5% Butenyl ALA
Topical application of sham control
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne, Photodynamic Therapy

Eligibility Criteria

19 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Seoul National Unviersity

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

1.5% Butenyl ALA

Control

Arm Description

Topical application of 1.5% Butenyl ALA per every other day around acne lesions in the face

Topical application of sham control per every other day around acne lesions in the face

Outcomes

Primary Outcome Measures

Percent change of inflammatory acne lesions compared with baseline

Secondary Outcome Measures

Percent change of non-inflammatory acne lesions compared with baseline
Percent change of overall severity of acne lesions compared with baseline

Full Information

First Posted
December 8, 2014
Last Updated
March 10, 2015
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02313467
Brief Title
Topical PDT Cream Without Irradiation Source in the Acne Treatment
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 Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne, Photodynamic Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.5% Butenyl ALA
Arm Type
Active Comparator
Arm Description
Topical application of 1.5% Butenyl ALA per every other day around acne lesions in the face
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Topical application of sham control per every other day around acne lesions in the face
Intervention Type
Drug
Intervention Name(s)
Topical application of 1.5% Butenyl ALA
Intervention Type
Drug
Intervention Name(s)
Topical application of sham control
Primary Outcome Measure Information:
Title
Percent change of inflammatory acne lesions compared with baseline
Time Frame
12 week
Secondary Outcome Measure Information:
Title
Percent change of non-inflammatory acne lesions compared with baseline
Time Frame
12 week
Title
Percent change of overall severity of acne lesions compared with baseline
Time Frame
12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Hun Suh, MD
Organizational Affiliation
Seoul National University Department of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National Unviersity
City
Seoul
State/Province
Seoul Metropolitan
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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Topical PDT Cream Without Irradiation Source in the Acne Treatment

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