CompletedPhase 4

Treatment of Nodular Basal Cell Carcinoma (BCC) With Imiquimod 5% Cream After Curettage

United States15 participantsStarted 2005-03

Plain-language summary

To assess the efficacy of treating a nodular basal cell carcinoma with imiquimod cream after initial treatment with curettage

Age range18 Years

SexALL

See this in plain English?

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

✓. Are willing and able to give informed consent;
✓. Are at least 18 years of age;
✓. Are willing to comply with all study requirements, evaluations, and procedures
✓. Have 1 clinically typical, visible nodular BCC lesion which meets the following criteria:
✓. Are free of any significant physical abnormalities or previous scarring in the potential application site area that may cause difficulty with examinations.
✓. Are willing to stop using over-the-counter retinol products or products containing alpha or beta hydroxyacids in the treatment and surrounding area 8 hours prior to treatment with the imiquimod cream and clinic visits.

✕. Have evidence of clinically significant, unstable, cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease that may interfere with completion of the study.
✕. Have any dermatological disease in the treatment or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination.
✕. Have a BCC lesion located within 1 cm of the eyes, nose, mouth, ear, and hairline.
✕. Are pregnant at the screening or treatment initiation visit.
✕. Have known allergies to any excipient in the study cream
✕. Have undergone any surgical procedures in the potential treatment area within 4 weeks of the screening/treatment initiation visit. In addition, skin in the potential application area must be healed.

histologic clearance of basal cell carcinoma

NCT IDNCT00314756

SponsorWake Forest University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Who can participate

Age range18 Years

SexALL

See this in plain English?

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

✓. Are willing and able to give informed consent;
✓. Are at least 18 years of age;
✓. Are willing to comply with all study requirements, evaluations, and procedures
✓. Have 1 clinically typical, visible nodular BCC lesion which meets the following criteria:
✓. Are free of any significant physical abnormalities or previous scarring in the potential application site area that may cause difficulty with examinations.
✓. Are willing to stop using over-the-counter retinol products or products containing alpha or beta hydroxyacids in the treatment and surrounding area 8 hours prior to treatment with the imiquimod cream and clinic visits.

✕. Have evidence of clinically significant, unstable, cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease that may interfere with completion of the study.
✕. Have any dermatological disease in the treatment or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination.
✕. Have a BCC lesion located within 1 cm of the eyes, nose, mouth, ear, and hairline.
✕. Are pregnant at the screening or treatment initiation visit.
✕. Have known allergies to any excipient in the study cream
✕. Have undergone any surgical procedures in the potential treatment area within 4 weeks of the screening/treatment initiation visit. In addition, skin in the potential application area must be healed.