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

This study has been completed.
Sponsor:
Information provided by:
Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT01245946
First received: November 22, 2010
Last updated: May 31, 2011
Last verified: November 2010
  Purpose
  • 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.

Condition Intervention Phase
Acne
Procedure: Photodynamic therapy
Drug: Conventional therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy Comparison Study of Topical Aminolaevulinic Acid-Photodynamic Therapy Versus Adapalene Gel 0.1% Plus Doxycycline for Treatment of Moderate Acne Vulgaris. Randomized, Simple Blind, Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:
  • Lesion counts [ Time Frame: Twelve weeks ] [ Designated as safety issue: No ]
    Be conducted by an investigator blinded to the interventions, count of inflammatory and non-inflammatory acne lesions at the start of treatment and controls at the sixth and twelfth week.


Secondary Outcome Measures:
  • Photographic scores, quality of life, adherence to treatment and global severity of acne [ Time Frame: Twelve weeks ] [ Designated as safety issue: No ]
    The researchers will make assessment of the quality of life, adherence to treatment, global severity of acne and scars and blemishes record at the beginning and end of the study (12 weeks).


Enrollment: 46
Study Start Date: October 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Photodynamic therapy 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
Other Name: PDT
Experimental: Conventional therapy Drug: Conventional therapy
Conventional therapy: Topical adapalene gel 0.1% at night for 12 weeks plus doxycycline 100 mg / day for 6 weeks.
Other Name: Adapalene plus doxycycline

Detailed Description:
  • There will be a randomized, controlled, single blind comparison study of PDT with 5-aminolevulinic acid (ALA) 20% versus conventional therapy consisting of topical 0.1% adapalene plus doxycycline 100 mg/day orally in patients with moderate inflammatory acne.
  • Be sought from all patients written informed consent prior to study entry.
  • For sample size calculation, we assumed that the correlation is the same in both groups and is relatively low (0.01), the number of lesions per subject is equal in both groups with a mean of 100 and low variance, which take 1 control per case and that. Whereas the percentage of improvement in the control group is 0.6 and expected in the treatment group is 0.7 yields a sample size of 23 patients in the treatment group and 23 new controls.

Interventions:

Patients will be randomized to receive:

  1. ALA-PDT: In 23 patients applied 20% ALA solution in the affected area for 1.5 hours. Subsequently irradiated with noncoherent red light (lamp Waldmann PDT 1200; wavelength 590-700 nm) with irradiance of 70 mW/cm2 and total dose or fluence of 37 J/cm2 for 7-9 minutes. From the sixth week will begin nightly topical adapalene 0.1% gel.
  2. Standard therapy:

In 23 patients applied topical adapalene 0.1% gel at night for 12 weeks plus doxycycline 100 mg / day for 6 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women between 18 and 30 years of age with moderate inflammatory acne

Exclusion Criteria:

  • Those who have received any treatment for acne either topic in the last 3 months before and systemic (including ACO started) in the last 6 months of the study.
  • Patients who are pregnant or breastfeeding.
  • Patients with history of photosensitivity or autoimmune disease.
  • Patients with a history or active TB disease or HIV.
  • Patient refusal to participate in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245946

Locations
Chile
Departamento de dermatología, Centro Médico San Joaquín, Pontificia Universidad Católica de Chile
Santiago, San Joaquín, Chile, 1234
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
Study Chair: Ariel Hasson, MD Dermatology department, Pontificia Universidad Católica de Chile
  More Information

No publications provided

Responsible Party: Claudia Nicklas D, Department of Dermatology, Pontificia Universidad Católica de Chile, Pontificia Universidad Católica de Chile
ClinicalTrials.gov Identifier: NCT01245946     History of Changes
Other Study ID Numbers: 10-146
Study First Received: November 22, 2010
Last Updated: May 31, 2011
Health Authority: Chile: Pontificia Universidad Católica de Chile

Keywords provided by Pontificia Universidad Catolica de Chile:
Acne moderate
Photodynamic Therapy
Topical retinoids
Antimicrobial agents

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Doxycycline hyclate
Anti-Infective Agents
Doxycycline
Adapalene
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 29, 2014