Topical Vitamin C for Treatment of Basal Cell Cancer

Overview

Open label pilot study of a 30% solution of ascorbic acid in 95% dimethylsulfoxide applied topically twice a day for 8 weeks as a treatment for 6 biopsy proven basal cell carcinomas in 4 otherwise healthy adult patients. Outcome measure was biopsy proven resolution of the carcinoma.

Full Title of Study: “Topical Ascorbic Acid for Treatment of Basal Cell Carcinoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 1, 2019

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 (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.

Design, Setting, and Participants

This case series of 4 patients with 6 lesions was conducted after biopsy proven diagnosis of basal cell cancer. All 4 patients sought initial non-surgical treatment. All 4 had an appointment set for Mohs surgery 10 wks after study enrollment, so in the event of treatment failure no further delay in definitive treatment would occur. Three patients were female, 1 male, and all were over the age of 50.

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.

Main Outcomes and Measures

Number of lesions out of a total of six that were cancer free after 8 wks of treatment.

Interventions

  • Drug: Topical Ascorbic Acid
    • Twice daily application of 300 microliters of 30% ascorbic acid solution with a small cuticle brush.

Arms, Groups and Cohorts

  • Experimental: Treatment group
    • Participants applied topical solution of ascorbic acid twice daily for 8 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Lesion Resolution
    • Time Frame: 8 weeks
    • Number of lesions resolved out of total of 6 treated.

Participating in This Clinical Trial

Inclusion Criteria

  • Presence of biopsy proven basal cell carcinoma

Exclusion Criteria

  • Absence of basal cell carcinoma

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Center for Biomedical Research, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Briant Burke, MD, Principal Investigator, CBR,Inc.

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