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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01245946
Recruitment Status : Completed
First Posted : November 23, 2010
Last Update Posted : June 1, 2011
Information provided by:
Pontificia Universidad Catolica de Chile

Brief 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.


  • 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 or disease Intervention/treatment Phase
Acne Procedure: Photodynamic therapy Drug: Conventional therapy Phase 2

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.


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : October 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Lesion counts [ Time Frame: Twelve weeks ]
    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 :
  1. Photographic scores, quality of life, adherence to treatment and global severity of acne [ Time Frame: Twelve weeks ]
    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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01245946

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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
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Study Chair: Ariel Hasson, MD Dermatology department, Pontificia Universidad Católica de Chile

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Responsible Party: Claudia Nicklas D, Department of Dermatology, Pontificia Universidad Católica de Chile, Pontificia Universidad Católica de Chile Identifier: NCT01245946    
Other Study ID Numbers: 10-146
First Posted: November 23, 2010    Key Record Dates
Last Update Posted: June 1, 2011
Last Verified: November 2010
Keywords provided by Pontificia Universidad Catolica de Chile:
Acne moderate
Photodynamic Therapy
Topical retinoids
Antimicrobial agents
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents