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Photodynamic Therapy Compared to Adapalene 0.1% Gel Plus Doxycycline in the Treatment of Acne Vulgaris

NCT01245946 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2011-06-01

No results posted yet for this study

Summary

* Acne vulgaris is a common inflammatory skin disease that affects more than 85% of teens and some people may continue throughout adulthood.
* Topical retinoids related to oral antibiotics are considered first-line treatment of moderate inflammatory acne.
* Recently, photodynamic therapy (PDT) with a photosensitizer, 5-aminolevulinic acid (ALA) or methyl aminolevulinate (MAL), has proven useful in the management of inflammatory acne. Although progress has been made in the study of photodynamic therapy for acne, to date, no study has compared PDT with standard and well-validated pharmaceutical treatments and with the current recommended therapy for most types of acne combination therapy with a topical retinoid plus one or more antimicrobial agents.

Hypothesis

* PDT with the photosensitizer ALA will be effective and safe for the treatment of moderate facial inflammatory acne.
* The ALA-PDT is more effective than conventional therapy with oral antibiotics and topical retinoids in the treatment of moderate inflammatory acne with faster action at 12 weeks of follow-up.

Conditions

Interventions

PROCEDURE

Photodynamic therapy

Photodynamic therapy: 2 sessions separated by 2 weeks of TDF with topical ALA20% for 1.5 hrs, then irradiated with red light (Waldmann lamp) at a fluence of 37 J/cm2 for 7-9 minutes. From the sixth week will begin adapalene 0.1% gel until 12 weeks

DRUG

Conventional therapy

Conventional therapy: Topical adapalene gel 0.1% at night for 12 weeks plus doxycycline 100 mg / day for 6 weeks.

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Ariel Hasson, MD · Dermatology department, Pontificia Universidad Católica de Chile

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Chile

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01245946 on ClinicalTrials.gov