Efficacy of Methyl Aminolevulinate + Daylight in Patients With Facial Photodamage

Fundación Dermabase60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Facial Photodamage

Interventions

Methyl Aminolevulinate (MAL)DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

IPS Universitaria

Medellín, Antioquia, Colombia

Outcomes

Primary Outcomes

Global photodamage improvement

The primary outcome is global photodamage improvement 1 month after the third daylight PDT session, according to Dover´s photodamage scale.

Time frame: 1 month after third session

Secondary Outcomes

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).

Time frame: 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.

Time frame: 1 month after the third session

Sun irradiance and illuminance quantification

Sun irradiation and illuminance quantification during exposure

Time frame: During the 2 hours of each session

Adverse events

Any adverse event

Time frame: 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.

Time frame: 1 week after sessions 1,2 and 3

Quality of life assessment (Skindex-29 Instrument)

Time frame: Basal and 1 month after the third session

Data from ClinicalTrials.gov

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