Chemo patch for skin cancer shows promise in early trial
NCT ID NCT03646188
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new way to deliver the chemotherapy drug doxorubicin directly into basal cell skin cancer using tiny dissolving needles on a patch. The goal was to find a safe dose and see if it could completely remove the cancer. The study included 13 adults with small, untreated skin cancers, but was stopped early.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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13 people
The number who actually took part.
- Started
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Jun 2020
- Finished
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May 2021
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult males and females, 40+ years in general good health as assessed by the investigator. 2. BCC (subtype: superficial or nodular) confirmed histologically by diagnostic shave biopsy at the Screening Visit 3. Primary BCC (i.e., no previous treatment) 4. Lesion size ≥ 4 mm2 or 2 x 2 mm and ≤ 169 mm2 or 13 x 13 mm 5. Participant must have no other "clinically significant" abnormal findings in his/her medical history, physical examination or clinical laboratory test results as assessed by the investigator 6. Negative urine pregnancy at study entry for female of child bearing potential 7. Men and women of child-producing potential must agree to use adequate contraception according to standard instructions by the investigator until the completion of the study 8. Participant must to be willing to adhere to the instructions of the investigator and his or her research team 9. Participant must sign an Informed Consent Form prior to any study specific procedures and entry into the study Exclusion Criteria: 1. Evidence of clinically significant, unstable medical conditions as assessed by the investigator 2. Excisional biopsy performed on the lesion to be treated in this study 3. Recent therapy(ies) to the BCC treatment area 4. Recurrent BCC (previously treated) at the site presented for treatment 5. BCC lesion to be treated is located in an area where excisional biopsy is undesired or aesthetically unacceptable to the participant 6. Previously demonstrated sensitivity to doxorubicin or carboxymethyl cellulose. 7. Participant with other active malignancies with the exception of non-metastatic prostate cancer and carcinoma in situ of the skin and cervix 8. Concomitant disease requiring systemic immunosuppressive treatment 9. Genetic skin cancer disorder, e.g., basal cell nevus syndrome 10. Participant is pregnant or breastfeeding 11. Treatment with another investigational drug, device, or other intervention within 3 months prior to the Screening Visit 12. Existing condition or treatment within 3 months prior to the Screening Visit that may have impact on clinical outcome for the treatment of BCC or delay in wound healing from the elliptical excision
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Center for Clinical and Cosmetic Research
Aventura, Florida, 33180, United States
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Other studies related to the condition(s) this trial covers.
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