Efficacy of Methyl Aminolevulinate + Daylight in Patients With Facial Photodamage

Fundación Dermabase

Status and phase: Completed; Phase 2

Conditions: Facial Photodamage

Treatments: Drug: Methyl Aminolevulinate (MAL); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02139618

2013-01INT

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Methyl Aminolevulinate (MAL)

Experimental group

Description:

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)

Treatment:

Drug: Methyl Aminolevulinate (MAL)

Placebo

Placebo Comparator group

Description:

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)

Treatment:

Drug: Placebo