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

Acne Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01245946
• Other study ID #: 10-146
• Status: Completed
• Phase: Phase 2
• First received: November 22, 2010
• Last updated: May 31, 2011
• Start date: October 2010
• Est. completion date: May 2011

Study information

• Verified date: November 2010
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Pontificia Universidad Católica de Chile
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne
• Acne Vulgaris

Intervention

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.

Locations

Country	Name	City	State
Chile	Departamento de dermatología, Centro Médico San Joaquín, Pontificia Universidad Católica de Chile	Santiago	San Joaquín

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesion counts	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.	Twelve weeks	No
Secondary	Photographic scores, quality of life, adherence to treatment and global severity of acne	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).	Twelve weeks	No