Topical PDT Cream Without Irradiation Source in the Acne Treatment

NCT ID: NCT02313467

Last Updated: 2015-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-02-28

Brief Summary

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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

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Conditions

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Acne, Photodynamic Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1.5% Butenyl ALA

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

Group Type ACTIVE_COMPARATOR

Topical application of 1.5% Butenyl ALA

Intervention Type DRUG

Control

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

Group Type SHAM_COMPARATOR

Topical application of sham control

Intervention Type DRUG

Interventions

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Topical application of 1.5% Butenyl ALA

Intervention Type DRUG

Topical application of sham control

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dae Hun Suh

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dae Hun Suh, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Department of Dermatology

Locations

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Seoul National Unviersity

Seoul, Seoul Metropolitan, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUH-PDT2

Identifier Type: -

Identifier Source: org_study_id

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