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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02139618

Enrollment

Registered

2014-05-15

Start date

2014-04-30

Completion date

2014-10-31

Last updated

2015-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Photodamage

Keywords

Randomized-controlled-trial, Methyl-Aminolevulinate, Daylight, Photodynamic-therapy

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

Interventions

DRUGMethyl Aminolevulinate (MAL)

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).
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.
Sun irradiance and illuminance quantification	During the 2 hours of each session	Sun irradiation and illuminance quantification during exposure
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.
Quality of life assessment (Skindex-29 Instrument)	Basal and 1 month after the third session	Quality of life assessment (Skindex-29 Instrument)
Adverse events	From recruitment until 1 month after the third session	Any adverse event

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026