Efficacy of Methyl Aminolevulinate + Daylight in Patients With Facial Photodamage

Phase 2

Completed

• Conditions: Facial Photodamage
• Interventions: Drug: Methyl Aminolevulinate (MAL); Drug: Placebo

• Registration Number: NCT02139618
• Lead Sponsor: Fundación Dermabase

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-29
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-15
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methyl Aminolevulinate (MAL)	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)
Placebo	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)

Primary Outcome Measures

Name	Time	Method
Global photodamage improvement	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.

Secondary Outcome Measures

Name	Time	Method
Therapy tolerance	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.
Pain measurement	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).
Sun irradiance and illuminance quantification	During the 2 hours of each session	Sun irradiation and illuminance quantification during exposure
Specific Photodamage score	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.
Adverse events	From recruitment until 1 month after the third session	Any adverse event
Quality of life assessment (Skindex-29 Instrument)	Basal and 1 month after the third session	Quality of life assessment (Skindex-29 Instrument)

Trial Locations

Locations (1)

IPS Universitaria; 🇨🇴 Medellin, Antioquia, Colombia