Photodynamic Therapy Compared to Adapalene 0.1% Gel Plus Doxycycline in the Treatment of Acne Vulgaris
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): Photodynamic therapy; Conventional therapy
Intervention type(s): Procedure; Drug
Intervention description(s): 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; Conventional therapy: Topical adapalene gel 0.1% at night for 12 weeks plus doxycycline 100 mg / day for 6 weeks.
Other intervention name(s): PDT; Adapalene plus doxycycline
Intervention MeSH terms: Doxycycline; Adapalene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne moderate; Photodynamic Therapy; Topical retinoids; Antimicrobial agents