CompletedPhase 1

Study of Methyl Aminolaevulinate Photodynamic Therapy With and Without Er:YAG Laser in Actinic Cheilitis

South Korea33 participantsStarted 2012-01

Plain-language summary

Methyl aminolaevulinate photodynamic therapy (MAL-PDT) is advantageous in that it has few cosmetic side effects and minimises patient discomfort. However, its relatively low efficacy prevents its application to the treatment of actinic cheilitis(AC). Er:YAG ablative fractional laser (AFL) treatment removes the stratum corneum to increase MAL uptake and may improve efficacy. However, no studies have directly compared the efficacy of MAL-PDT with and without Er:YAG AFL in treating AC

Who can participate

Age range18 Years – 92 Years

SexALL

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

Inclusion Criteria: * Korean patients ≥ 18 years of age who had biopsy-confirmed AC lesions Exclusion Criteria: * porphyria * known allergies to the MAL cream or lidocaine * pregnancy * lactation * any active systemic infectious disease * immunosuppressive treatment * personal history of malignant melanoma * tendency towards melasma or keloid formation * prior treatment of the lesions within 4 weeks * any indication of poor compliance

What they're measuring

Difference the efficacy between Er:YAG AFL-assisted MAL-PDT (Er:YAG AFL MAL-PDT) and standard MAL-PDT.

Timeframe: Efficacy was evaluated at 3 months and 12 months after treatment

Trial details

NCT IDNCT02198469

SponsorDong-A University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-03

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