Efficacy of Methyl Aminolevulinate + Daylight in Patients With Facial Photodamage

A Double-blind Randomized-controlled Trial to Assess the Efficacy of Methyl Aminolevulinate + Daylight vs Placebo + Daylight in Patients With Facial Photodamage

Treatment of actinic damage has included multiple procedures but to date there is limited scientific evidence to support the preferential use of one of these therapies according to their efficacy, safety and pain tolerance by patients. This study aims to assess the efficacy of methyl aminolevulinate + daylight vs placebo + daylight to treat facial photodamage

Study Overview

• Status: Completed
• Conditions: Facial Photodamage
• Intervention / Treatment: Drug: Placebo; Drug: Methyl Aminolevulinate (MAL)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 01
      • IPS Universitaria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults with symmetric facial photodamage grade 2 or 3 (Dover´s scale)
• Patients willing to participate
• Signed informed consent

Exclusion Criteria:

• Pregnant or nursing females
• Subjects with any photosensitizing disorder
• Any active infectious skin disorder
• History of herpes simplex in the face
• Subjects with less than 6 months of any previous rejuvenation interfering treatments
• History of systemic isotretinoin in the last year
• Subjects requiring concurrent treatment that would interfere with study objectives and/or assessments
• History of hypersensitivity reactions
• Activities with high sun exposure during 48 hours after treatment
• Clinical suspicion of any systemic or local malignancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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)	Drug: Placebo; Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global photodamage improvement	The primary outcome is global photodamage improvement 1 month after the third daylight PDT session, according to Dover´s photodamage scale.	1 month after third session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain measurement	Pain evaluation with the visual analogue scale after 2 hours of sun exposure in each of the sessions performed (Sessions 1, 2 and 3).	After 2 hours of sun exposure in each session
Specific Photodamage score	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.	1 month after the third session
Sun irradiance and illuminance quantification	Sun irradiation and illuminance quantification during exposure	During the 2 hours of each session
Adverse events	Any adverse event	From recruitment until 1 month after the third session
Therapy tolerance	Therapy tolerance will be recorded with a scale that includes a 4-grade severity score for oozing, erythema, oedema, desquamation, pigmentation, and vesiculation.	1 week after sessions 1,2 and 3
Quality of life assessment (Skindex-29 Instrument)	Quality of life assessment (Skindex-29 Instrument)	Basal and 1 month after the third session

Collaborators and Investigators

• Sponsor: Fundación Dermabase
• Collaborators: IPS Universitaria-Universidad de Antioquia; Grupo de Investigacion Dermatologica (GRID)
• Investigators: Principal Investigator: Gloria Sanclemente, Dr, Universidad de Antioquia. Medellin, Colombia

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: April 29, 2014
• First Submitted That Met QC Criteria: May 13, 2014
• First Posted (Estimate): May 15, 2014

Study Record Updates

• Last Update Posted (Estimate): March 6, 2015
• Last Update Submitted That Met QC Criteria: March 5, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Randomized-controlled-trial; Methyl-Aminolevulinate; Daylight; Photodynamic-therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid; Methyl 5-aminolevulinate
• Other Study ID Numbers: 2013-01INT