Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT01245946
Study type Interventional
Source Pontificia Universidad Catolica de Chile
Contact
Status Completed
Phase Phase 2
Start date October 2010
Completion date May 2011

See also
  Status Clinical Trial Phase
Completed NCT05097157 - Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions N/A
Completed NCT05131373 - Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris Phase 1
Completed NCT04806594 - Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar. N/A
Recruiting NCT03465150 - Creation of a Monocentric Cohort of Patients Treated for Acne at the Nantes University Hospital
Completed NCT02250859 - A Pharmacokinetic Study of Minocycline in Male and Female Volunteers Phase 1
Completed NCT01206348 - Combination Treatment for Moderate to Severe Acne Phase 4
Terminated NCT01193764 - Study Assessing the Effect of Chocolate Consumption in Subjects With A History of Acne Vulgaris N/A
Completed NCT00725439 - An Open Label Trial to Assess the Safety and Efficacy of Oral R115866 in the Treatment Facial Acne Phase 2
Completed NCT05640388 - Assessment of a Cosmetic Product Effect on the Host/Microorganism Relationship in Acneic Subjects
Completed NCT04873089 - Efficacy Study of Cosmetic Product RV3278AET0943 Versus Non-treated Group in Adults With Oily and Acne Prone Skin
Recruiting NCT05941065 - Study of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin N/A
Recruiting NCT06120452 - A Clinical Trial to Evaluate the Effectiveness of an Acne Serum in Improving Facial Acne and Post-Acne Pigmentation N/A
Completed NCT04300010 - Blue Light Therapy of C. Acnes Phase 4
Recruiting NCT06202274 - Clinical Study to Evaluate the Safety and Efficacy of Candela Technology N/A
Completed NCT04559022 - Pilot Study Investigating the Efficacy of Fat Grafting as a Treatment for Male and Female Facial Acne Scarring N/A
Terminated NCT02431494 - Safety and Preliminary Efficacy of Combination Therapy for the Treatment of Acne Vulgaris N/A
Completed NCT05469880 - Efficacy and Tolerance of Formula 609613 37 in Acneic Patients N/A
Completed NCT02944461 - Efficacy and Safety of Aczone 7.5% Gel in the Treatment of Truncal Acne Vulgaris Phase 4
Completed NCT01951417 - Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris Phase 4
Completed NCT01701024 - Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne Phase 3