Efficacy of Methyl Aminolevulinate + Daylight in Patients With Facial Photodamage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Facial Photodamage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

Methyl Aminolevulinate (MAL)

Intervention Type DRUG

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)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Methyl Aminolevulinate (MAL)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Metvix® Vehicle

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No