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NCT05932511 Clinical Trial

Topical Ascorbic Acid for Treatment of Squamous Cell Skin Cancer

Squamous Cell Carcinoma Clinical Trial

Official title:
Concentrated Ascorbic Acid in DMSO for Treatment of Squamous Cell Carcinoma of the Skin

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05932511
Other study ID # SCC_002
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date June 12, 2023
Est. completion date December 31, 2024

Study information
Verified date August 2023
Source Center for Biomedical Research, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 15
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: Presence of biopsy proven squamous cell cancer of the skin - Exclusion Criteria: Previous history of malignancy, diabetes, immunocompromised -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 30% ascorbic acid in DMSO
see above

Locations
Country Name City State
United States Center for Biomedical Research,Inc. Boise Idaho

Sponsors (1)
Lead Sponsor Collaborator
Center for Biomedical Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lesion Resolution Number of lesions tumor free by 2 mm punch biopsy post treatment 8 weeks
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