Efficacy of Methyl Aminolevulinate + Daylight in Patients With Facial Photodamage
|ClinicalTrials.gov Identifier: NCT02139618|
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : March 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Facial Photodamage||Drug: Methyl Aminolevulinate (MAL) Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Double-blind Randomized-controlled Trial to Assess the Efficacy of Methyl Aminolevulinate + Daylight vs Placebo + Daylight in Patients With Facial Photodamage|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Experimental: Methyl Aminolevulinate (MAL)
1 gram of Topical Methyl Aminolevulinate (MAL) applied to the whole face 30 minutes before sun exposure for 2 hours (3 sessions , 2 to 4 weeks apart)
Drug: Methyl Aminolevulinate (MAL)
Other Name: Metvix®
Placebo Comparator: Placebo
1 gram of placebo cream applied to the whole face 30 minutes before sun exposure for 2 hours (3 sessions , 2 to 4 weeks apart)
Other Name: Vehicle
- Global photodamage improvement [ Time Frame: 1 month after third session ]The primary outcome is global photodamage improvement 1 month after the third daylight PDT session, according to Dover´s photodamage scale.
- Pain measurement [ Time Frame: After 2 hours of sun exposure in each session ]Pain evaluation with the visual analogue scale after 2 hours of sun exposure in each of the sessions performed (Sessions 1, 2 and 3).
- Specific Photodamage score [ Time Frame: 1 month after the third session ]Specific photodamage severity score for fine lines, coarse lines, tactile roughness, mottled pigmentation, sallowness, and erythema one month after the third daylight PDT session, according to Dover´s photodamage scale.
- Sun irradiance and illuminance quantification [ Time Frame: During the 2 hours of each session ]Sun irradiation and illuminance quantification during exposure
- Adverse events [ Time Frame: From recruitment until 1 month after the third session ]Any adverse event
- Therapy tolerance [ Time Frame: 1 week after sessions 1,2 and 3 ]Therapy tolerance will be recorded with a scale that includes a 4-grade severity score for oozing, erythema, oedema, desquamation, pigmentation, and vesiculation.
- Quality of life assessment (Skindex-29 Instrument) [ Time Frame: Basal and 1 month after the third session ]Quality of life assessment (Skindex-29 Instrument)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139618
|Medellin, Antioquia, Colombia, 01|
|Principal Investigator:||Gloria Sanclemente, Dr||Universidad de Antioquia. Medellin, Colombia|