Departamento de dermatología, Centro Médico San Joaquín, Pontificia Universidad Católica de Chile
Santiago, San Joaquín, 1234, Chile
NCT Number: NCT01245946
* 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.
Looking for future studies?
Notify Me18 year–30 year
All sexes
Interventional
Phase 2
Santiago, San Joaquín, 1234, Chile
Interventions:
Patients will be randomized to receive:
In 23 patients applied topical adapalene 0.1% gel at night for 12 weeks plus doxycycline 100 mg / day for 6 weeks.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: PDT
Conventional therapy: Topical adapalene gel 0.1% at night for 12 weeks plus doxycycline 100 mg / day for 6 weeks.
Other names: Adapalene plus doxycycline
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.
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).
Pontificia Universidad Catolica de Chile
Other
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.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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