CompletedPhase 3

Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage

Colombia49 participantsStarted 2008-02

Plain-language summary

The aim of the study is to determine the efficacy of MAL + Aktilite versus placebo + Aktilite in facial photodamage in a randomized double blind trial.

Who can participate

Age range

35 Years – 75 Years

Sex

FEMALE

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: * Female subjects older than 35 years of age and less than 75 years of age * Subjects with a photodamage grade of 2 or 3 according to a modified Dover´s Global photodamage scale * Subjects willing to participate according to protocol requirements. * Patients with signed Informed Consent * Patients with no exclusion criteria Exclusion Criteria: * Pregnant or nursing females. * Subjects with suspected porphyria, Systemic or cutaneous erythematosus lupus, or any other photosensitizing disorder or drug induced photosensitization. * Any active infectious skin disorder ( Herpes simplex, molluscum contagiosum, facial warts ) * Subjects with less than 6 months of previous rejuvenation interfering treatments * Subjects requiring concurrent treatment that would interfere with study objectives and/or assessments.

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

Efficacy in facial global photodamage

Timeframe: 8 months

Trial details

NCT IDNCT00629317

SponsorUniversidad de Antioquia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-01

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