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Topical Vitamin C for Treatment of Basal Cell Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04279535
Recruitment Status : Completed
First Posted : February 21, 2020
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Center for Biomedical Research, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Drug: Topical Ascorbic Acid Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topical Ascorbic Acid for Treatment of Basal Cell Carcinoma
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arm Intervention/treatment
Experimental: Treatment group
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.




Primary Outcome Measures :
  1. Lesion Resolution [ Time Frame: 8 weeks ]
    Number of lesions resolved out of total of 6 treated.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of biopsy proven basal cell carcinoma

Exclusion Criteria:

  • Absence of basal cell carcinoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04279535


Locations
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United States, Idaho
Center for Biomedical Research,Inc.
Boise, Idaho, United States, 83706
Sponsors and Collaborators
Center for Biomedical Research, Inc.
Investigators
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Principal Investigator: Briant Burke, MD CBR,Inc.

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Responsible Party: Center for Biomedical Research, Inc.
ClinicalTrials.gov Identifier: NCT04279535    
Other Study ID Numbers: BCC-001
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Ascorbic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances