Facial Photodamage Clinical Trial
Official title:
A Double-blind Randomized-controlled Trial to Assess the Efficacy of Methyl Aminolevulinate + Daylight vs Placebo + 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
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 35 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Colombia | IPS Universitaria | Medellin | Antioquia |
| Lead Sponsor | Collaborator |
|---|---|
| Fundación Dermabase | Grupo de Investigacion Dermatologica (GRID), IPS Universitaria-Universidad de Antioquia |
Colombia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | Pain measurement | Pain evaluation with the visual analogue scale after 2 hours of sun exposure in each of the sessions performed (Sessions 1, 2 and 3). | After 2 hours of sun exposure in each session | No |
| Secondary | Specific Photodamage score | 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. | 1 month after the third session | No |
| Secondary | Sun irradiance and illuminance quantification | Sun irradiation and illuminance quantification during exposure | During the 2 hours of each session | No |
| Secondary | Adverse events | Any adverse event | From recruitment until 1 month after the third session | Yes |
| Secondary | Therapy tolerance | Therapy tolerance will be recorded with a scale that includes a 4-grade severity score for oozing, erythema, oedema, desquamation, pigmentation, and vesiculation. | 1 week after sessions 1,2 and 3 | Yes |
| Secondary | Quality of life assessment (Skindex-29 Instrument) | Quality of life assessment (Skindex-29 Instrument) | Basal and 1 month after the third session | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03559972 -
Study to Evaluate Efficacy and Tolerability of Two Topical Regimens in Subjects With Moderate to Severe Facial Photodamage Who Have Received Cosmetic Injections
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N/A |