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OpenTrials
Completed

NCT Number: NCT02139618

Efficacy of Methyl Aminolevulinate + Daylight in Patients With Facial Photodamage

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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Key information

Conditions

Facial Photodamage

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IPS Universitaria

Medellín, Antioquia, 01, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methyl Aminolevulinate (MAL)

Drug

Other names: Metvix®

Placebo

Drug

Other names: Vehicle

Primary outcomes

  1. Global photodamage improvement

    Time frame: 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 outcomes

  1. Pain measurement

    Time frame: 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).

  2. Specific Photodamage score

    Time frame: 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.

  3. Sun irradiance and illuminance quantification

    Time frame: During the 2 hours of each session

    Sun irradiation and illuminance quantification during exposure

  4. Adverse events

    Time frame: From recruitment until 1 month after the third session

    Any adverse event

  5. Therapy tolerance

    Time frame: 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.

  6. Quality of life assessment (Skindex-29 Instrument)

    Time frame: Basal and 1 month after the third session

    Quality of life assessment (Skindex-29 Instrument)

Sponsors and collaborators

Lead sponsor

Fundación Dermabase

Other

Collaborators

  • Grupo de Investigacion Dermatologica (GRID)
  • IPS Universitaria-Universidad de Antioquia

Registry information

Official study title

A Double-blind Randomized-controlled Trial to Assess the Efficacy of Methyl Aminolevulinate + Daylight vs Placebo + Daylight in Patients With Facial Photodamage

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 15, 2014
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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