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Topical Ascorbic Acid for Treatment of Squamous Cell Skin Cancer

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05932511
Enrollment
15
Registered
2023-07-06
Start date
2023-06-12
Completion date
2024-12-31
Last updated
2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-melanoma Skin Cancer, Skin Cancer, Squamous Cell Cancer, Squamous Cell Carcinoma

Keywords

squamous cell cancer, skin cancer, non-melanoma skin cancer, squamous cell carcinoma

Brief 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.

Interventions

DRUG30% ascorbic acid in DMSO

see above

Sponsors

Center for Biomedical Research, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Open label pilot study

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

Presence of biopsy proven squamous cell cancer of the skin -

Exclusion criteria

Previous history of malignancy, diabetes, immunocompromised \-

Design outcomes

Primary

MeasureTime frameDescription
Lesion Resolution8 weeksNumber of lesions tumor free by 2 mm punch biopsy post treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026