Dose-Ranging Clinical Trial of Topical Creams Containing API 31510 for the Treatment of Superfici… (NCT00604890) | Clinical Trial Compass
CompletedPhase 1/2
Dose-Ranging Clinical Trial of Topical Creams Containing API 31510 for the Treatment of Superficial Basal Cell Carcinoma
United States186 participantsStarted 2008-03
Plain-language summary
The purpose of this study is to determine the safety and tolerability of pharmaceutical compound (API 31510) topical cream topically applied to superficial basal cell carcinomas to obtain preliminary efficacy data for the treatment of superficial basal cell carcinomas by API 31510 topical cream. The study population will include one hundred and sixty (160) otherwise healthy male or female adults with one or more histologically confirmed superficial basal cell carcinoma lesions. One target lesion with an area of less than one inch will be designated for study treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female adults ≥ 18 years of age
* Primary, histologically confirmed sBCC with a minimum area of 0.5 cm2 and with a maximum diameter of 2.0 cm target sBCC lesion suitable for excision
* Histological diagnosis made no more than 4 weeks prior to the screening visit
* Histological biopsy removed 25% or less of the target lesion
* No other dermatological disease in the sBCC target site or surrounding area
* Willing to refrain from using non-approved lotions or creams on the target site and surrounding area during the treatment period. Willing to refrain from washing the treated area for at least 8 hours following the application of study medication
* Willing to refrain from exposure to direct sunlight or ultraviolet light and to avoid the use of tanning parlors for the duration of the study
* Laboratory values for the tests listed in the Study Schedule on page 2 within the reference ranges as defined by the central laboratory, or "out of range" test results that are clinically acceptable to the investigator.
* Ability to follow study instructions and likely to complete all study requirements
* Written informed consent obtained, including consent for tissue to be examined and stored by the central dermatopathologist
* Written consent to allow photographs of the target sBCC lesion to be used as part of the study data
* For females of childbearing potential, a negative pregnancy test at screening and using an acceptable form of birth control (oral/impla…