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| Name | Class |
|---|---|
| Grupo de Investigacion Dermatologica (GRID) | UNKNOWN |
| IPS Universitaria-Universidad de Antioquia | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methyl Aminolevulinate (MAL) | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Specific Photodamage score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gloria Sanclemente, Dr | Universidad de Antioquia. Medellin, Colombia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IPS Universitaria | Medellín | Antioquia | 01 | Colombia |
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| ID | Term |
|---|---|
| C475457 | methyl 5-aminolevulinate |
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| Drug |
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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 |
| Sun irradiance and illuminance quantification | Sun irradiation and illuminance quantification during exposure | During the 2 hours of each session |
| Adverse events | Any adverse event | From recruitment until 1 month after the third session |
| 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 |
| Quality of life assessment (Skindex-29 Instrument) | Quality of life assessment (Skindex-29 Instrument) | Basal and 1 month after the third session |