Topical Vitamin C for Treatment of Basal Cell Cancer

Topical Ascorbic Acid for Treatment of Basal Cell Carcinoma

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.

Study Overview

• Status: Completed
• Conditions: Basal Cell Carcinoma
• Intervention / Treatment: Drug: Topical Ascorbic Acid

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, 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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Idaho
    • Boise, Idaho, United States, 83706
      • Center for Biomedical Research,Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Presence of biopsy proven basal cell carcinoma

Exclusion Criteria:

• Absence of basal cell carcinoma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ascorbic acid; Participants applied topical solution of ascorbic acid twice daily for 8 weeks	Drug: Topical Ascorbic Acid; Twice daily application of 300 microliters of 30% ascorbic acid solution with a small cuticle brush.
Active Comparator: Imiquimod; Participants applied 5% imiquimod cream topically 5x/week	Drug: Topical Ascorbic Acid; Twice daily application of 300 microliters of 30% ascorbic acid solution with a small cuticle brush.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion Resolution	Number of lesions resolved out of total of 6 treated.	8 weeks

Collaborators and Investigators

• Sponsor: Center for Biomedical Research, Inc.
• Investigators: Principal Investigator: Briant Burke, MD, CBR,Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: BCC-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No