CompletedPhase 1

Study of Methyl Aminolaevulinate Photodynamic Therapy With and Without Er:YAG Laser in Bowen's Disease

South Korea21 participantsStarted 2011-03

Plain-language summary

Methyl aminolaevulinate photodynamic therapy (MAL-PDT) is an effective treatment for Bowen's disease (BD) of the lower extremities. 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 BD of the lower extremities in Asians.

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 aged ≥ 18 years who had biopsy-confirmed BD lesions on the lower extremities 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, and * any indication of poor compliance

What they're measuring

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

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

Trial details

NCT IDNCT01912976

SponsorDong-A University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-03

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