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Trial Title:
Topical Ascorbic Acid for Treatment of Squamous Cell Skin Cancer
NCT ID:
NCT05932511
Condition:
Squamous Cell Cancer
Squamous Cell Carcinoma
Skin Cancer
Non-melanoma Skin Cancer
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Skin Neoplasms
Neoplasms, Squamous Cell
Ascorbic Acid
Conditions: Keywords:
squamous cell cancer
skin cancer
non-melanoma skin cancer
squamous cell carcinoma
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Open label pilot study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
30% ascorbic acid in DMSO
Description:
see above
Arm group label:
30% Ascorbic Acid in DMSO
Summary:
Randomized comparative 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 of
biopsy proven squamous cell carcinomas of the skin in otherwise healthy adult patients.
Outcome measure was biopsy proven resolution of the carcinoma.
Detailed description:
Importance:
Skin cancer is the most common cancer in the United States, with more people diagnosed
each year than all other cancers combined. Basal cell and squamous cell cancers are the
most common forms with an estimated 6-7 million cases diagnosed annually. Costs of
treating these cancers in the U.S. are estimated at $9-10 billion annually. Task force
consensus guidelines suggest Mohs surgery as the treatment of choice, and as the single
most precise and effective treatment method. However, cost and issues of cosmesis are
principal disadvantages. Previous studies show the effectiveness of a topical solution of
ascorbic acid in the treatment of BCC. This study extends previous work to evaluate
efficacy in the treatment of SCC of the skin.
Objective:
To evaluate efficacy of a therapeutic regimen in treating squamous 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 SCC.
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 SCC. Patients with cancers larger than 2 cm or deeper
than 2 mm were excluded from the study. Imiquimod was applied once daily for 5 days per
week as per manufacturer instructions for treatment of SCC. 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. 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 was intact.
Main Outcomes and Measures Number of lesions out that were cancer free after 8 wks of
treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria: Presence of biopsy proven squamous cell cancer of the skin -
Exclusion Criteria: Previous history of malignancy, diabetes, immunocompromised
-
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Center for Biomedical Research,Inc.
Address:
City:
Boise
Zip:
83706
Country:
United States
Status:
Recruiting
Contact:
Last name:
Briant Burke, MD
Phone:
208-353-0158
Email:
bburkemd2@gmail.com
Start date:
June 12, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Center for Biomedical Research, Inc.
Agency class:
Industry
Source:
Center for Biomedical Research, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05932511
