Efficacy of Methyl Aminolevulinate + Daylight in Patients With Facial Photodamage

NCT02139618 | Completed Phase 2

• 1 other identifier: 2013-01INT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Facial Photodamage

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Global photodamage improvement

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

  1 month after third session

Secondary Outcomes (6)

• Pain measurement

  After 2 hours of sun exposure in each session

• Specific Photodamage score

  1 month after the third session

• Sun irradiance and illuminance quantification

  During the 2 hours of each session

• Adverse events

  From recruitment until 1 month after the third session

• Therapy tolerance

  1 week after sessions 1,2 and 3

Study Arms (2)

Methyl Aminolevulinate (MAL)

EXPERIMENTAL

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)

Drug: Methyl Aminolevulinate (MAL)

Placebo

PLACEBO COMPARATOR

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)

Drug: Placebo

Interventions

Methyl Aminolevulinate (MAL) DRUG

Also known as: Metvix®

Methyl Aminolevulinate (MAL)

Placebo DRUG

Also known as: Vehicle

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with symmetric facial photodamage grade 2 or 3 (Dover´s scale)
• Patients willing to participate
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Dermabase: lead
• Grupo de Investigacion Dermatologica (GRID): collaborator
• IPS Universitaria-Universidad de Antioquia: collaborator

Study Sites (1)

IPS Universitaria

Medellín, Antioquia, 01, Colombia

Location

MeSH Terms

Interventions

methyl 5-aminolevulinate

Study Officials

• Gloria Sanclemente, Dr

  Universidad de Antioquia. Medellin, Colombia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 15, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

CO (1)