Study on Placebo Microneedles in Healthy Volunteers and Doxorubicin Microneedles for Basal Cell Cancer
Sponsor: SkinJect, Inc.
ClinicalTrials ID:NCT04928222
This clinical trial is exploring the use of microneedles in two parts: first, testing placebo microneedles in healthy volunteers, and second, testing doxorubicin microneedles in patients with basal cell cancer to evaluate their effectiveness and safety.
Patient Parameters
| Parameter | Options |
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Program Overview
The study is divided into two parts. Part I involves healthy volunteers to understand how different factors affect the dissolution of placebo microneedles on the skin. Part II involves patients with basal cell cancer, where doxorubicin microneedles will be tested to see if they can effectively treat the cancer. Participants will be randomly assigned to receive either a placebo or one of three doses of doxorubicin microneedles.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 and older in good health.
- Blood and kidney function within specified limits.
- No significant health issues as determined by the study doctor.
- Willingness to follow study instructions and sign a consent form.
- For cancer patients: confirmed basal cell cancer by biopsy, with specific lesion size and no prior treatment.
- Women must be postmenopausal, surgically sterile, or use effective contraception and have negative pregnancy tests.
- Men must use contraception if their partners can become pregnant.
Exclusion Criteria
- Unstable medical conditions.
- Allergy to doxorubicin or certain substances.
- Pregnant or breastfeeding women.
- Serious illnesses or conditions requiring blood thinners.
- Recent topical treatments or surgeries on the cancer lesion.
- Previously treated or recurrent basal cell cancer at the treatment site.
- Other active cancers, except for certain non-threatening types.
- Participation in another study within the last month.
- Skin conditions near the cancer lesion that could affect results.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Beer Dermatology | 33411 | West Palm Beach | Florida |
| New York and Presbyterian Hospital | 10032 | New York | New York |
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