CompletedPhase 2

Efficacy of Methyl Aminolevulinate + Daylight in Patients With Facial Photodamage

Colombia60 participantsStarted 2014-04

Plain-language 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

Who can participate

Age range

35 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Global photodamage improvement

Timeframe: 1 month after third session

Trial details

NCT IDNCT02139618

SponsorFundación Dermabase

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-10

View on ClinicalTrials.gov More Facial Photodamage trials