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

NCT01245946 | Completed Phase 2 DMC

• 1 other identifier: 10-146
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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. 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

Acne

Keywords

Acne moderate; Photodynamic Therapy; Topical retinoids; Antimicrobial agents

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Photographic scores, quality of life, adherence to treatment and global severity of acne

  Twelve weeks

Study Arms (2)

Photodynamic therapy

EXPERIMENTAL

Procedure: Photodynamic therapy

Conventional therapy

EXPERIMENTAL

Drug: Conventional therapy

Interventions

Photodynamic therapy PROCEDURE

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

Also known as: PDT

Photodynamic therapy

Conventional therapy DRUG

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

Also known as: Adapalene plus doxycycline

Conventional therapy

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Departamento de dermatología, Centro Médico San Joaquín, Pontificia Universidad Católica de Chile

Santiago, San Joaquín, 1234, Chile

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Photochemotherapy; 1-phenyl-3,3-dimethyltriazene; Adapalene; Doxycycline

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Tetracyclines; Naphthacenes

Study Officials

• Ariel Hasson, MD

  Dermatology department, Pontificia Universidad Católica de Chile

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 23, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 1, 2011

Record last verified: 2010-11

Locations

CL (1)