Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04279535 |
| Other study ID # |
BCC-001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2018 |
| Est. completion date |
June 1, 2019 |
Study information
| Verified date |
October 2021 |
| Source |
Center for Biomedical Research, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Randomized coomparative trial of a 30% solution of ascorbic acid in 95% dimethylsulfoxide
applied topically twice a day for 8 weeks vs 5% imiquimod cream in the treatment biopsy
proven basal cell carcinomas inotherwise healthy adult patients. Outcome measure was biopsy
proven resolution of the carcinoma.
Description:
Importance
Skin cancer is the most common cancer in the United States, with more people diagnosed each
year than all other cancers combined (1). Basal cell cancer is the most common form with an
estimated 4.3 million cases diagnosed annually (2,3). Costs of treating this cancer in the
U.S. are estimated at $4.8 billion annually (4). Task force consensus guidelines suggest Mohs
surgery as the treatment of choice, and as the single most precise and effective treatment
method (5). However, cost and issues of cosmesis are principal disadvantages.
Objective
To evaluate efficacy of a therapeutic regimen in treating basal cell cancer, consisting of
30% ascorbic acid in 95% dimethylsulfoxide topically applied at home by patients twice a day
for 8 weeks, vs 5% imiquimod cream which is an FDA approved treatment for BCC.
Design, Setting, and Participants This study was carried out in accordance with principles of
the Declaration of Helsinki. Detailed informed consent was obtained from each patient.
Eligible participants of any age had histologically confirmed primary, previously untreated,
nodular or superficial BCC not arising at sites of high risk for sub clinical tumor spread
(the nose, ear, eyelid, eyebrow, or temple ( )). Patients with infiltrative, recurrent, or
morphoeic BCC were excluded from the study. Imiquimod was applied once daily for 5 days per
week as per manufacturer instructions for treatment of BCC. Patients were randomly assigned
to treatment group. Participants and outcome assessors were blinded to treatment protocol.
Patients were seen at initial visit, 4 weeks, 8 weeks, and six weeks after treatment
conclusion for final biopsy. Those participants in the IMQ group who continued through 12
weeks of treatment were seen for an additional visit. The AA treatment was a solution while
the IMQ a cream, however participants were simply told they would be receiving a topical
treatment with instructions on how to apply, thus the blinding remained intact.
Histopathology showed 21 nodular and 8 superficial BCC subtypes upon enrollment. Thirteen
patients (8 female 5 male) with a total of 15 lesions were randomized to the ascorbic acid
(AA) treatment group, and 12 patients (6 female 6 male) with 14 lesions were randomized to
the imiquimod group (IMQ). There was no difference in mean size of BCC in each group ( 11.4
+/-2.1 mm vs. 13.1 +/- 1.9mm). The AA group had 11 nodular and 4 superficial BCC and the IMQ
group 10 nodular and 4 superficial.
Histopathology was confirmed by 2mm partial punch biopsy leaving
the bulk of the BCC intact prior to treatment. Patients in the AA group were treated
twice daily 7 days per week with a topical solution of 30% (w/v) ascorbic acid solution in
95% (v/v) dimethylsulfoxide (DMSO) and
5% (v/v) distilled water, while the IMQ patients received twice daily application of a
commercial 5% cream 5 days per week according to manufacturer recommendations for treatment
of BCC. Application was made with a small cuticle brush in the AA group. Patient compliance
was high and no
patient had difficulty with the application. Volume of the ascorbic acid solution applied was
0.2-0.3ml per application. Treatment was
continued for 8 wks or until the lesion cleared. Subjects in the IMQ group whose lesions had
failed to resolve at 8 weeks were treated for an additional 4 weeks in conformity with
reports showing better outcomes with 12 weeks of treatment with IMQ ( ).
All patients had an appointment set for Mohs surgery
after study enrollment, so in the event of treatment failure no further delay in definitive
treatment would occur.
Repeat 2mm punch biopsy of each site was taken at the conclusion of the study. Patients were
seen in follow up after
12, 24, and 30 months
Interventions
An 8 wk therapeutic regimen of topical 30% (w/v) ascorbic acid, 95% (v/v) dimethylsulfoxide,
and 5% (v/v) distilled water applied twice daily at home, or 5% imiquimod cream applied 5/wk
according to manufacturer recommendations for treating BCC.
Main Outcomes and Measures
Number of lesions out that were cancer free after 8 wks of treatment.
