Squamous Cell CancerEarly Phase 1NCT05932511
Topical Ascorbic Acid for Treatment of Squamous Cell Skin Cancer
A Early Phase 1 study testing 30% ascorbic acid in DMSO in people with Squamous Cell Cancer and Squamous Cell Carcinoma, run by Center for Biomedical Research, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Squamous Cell Cancer, Squamous Cell Carcinoma, Skin Cancer
- What is being tested?
- 30% ascorbic acid in DMSO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2023to 31 Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Presence of biopsy proven squamous cell cancer of the skin -
Exclusion Criteria: Previous history of malignancy, diabetes, immunocompromised
-
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Center for Biomedical Research,Inc.
Boise, Idaho, 83706
Briant Burke, MD, 208-353-0158, bburkemd2@gmail.com
About this study
Official title: Concentrated Ascorbic Acid in DMSO for Treatment of Squamous Cell Carcinoma of the Skin
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.
Read the 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.
- Being tested
- 30% ascorbic acid in DMSO
- Keywords
- squamous cell cancer, skin cancer, non-melanoma skin cancer, squamous cell carcinoma
- Medical subject headings
- Neoplasms, Squamous Cell, Carcinoma, Squamous Cell, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30% ascorbic acid in DMSODrug
see above
| Study group | Role | What they receive |
|---|---|---|
| 30% Ascorbic Acid in DMSO | Experimental | Topical application twice daily of 300ul 30% (w/v) solution of ascorbic acid in DMSO Receives: Drug: 30% ascorbic acid in DMSO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion Resolution
Number of lesions tumor free by 2 mm punch biopsy post treatment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start12 Jun 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label pilot study
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Biomedical Research, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932511
- Sponsor's protocol ID
- SCC_002
- Status last verified
- Aug 2023
- First submitted
- 21 Jun 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concentrated Ascorbic Acid in DMSO for Treatment of Squamous Cell Carcinoma of the Skin
- ClinicalTrials.gov ID
- NCT05932511
- Acronym / sponsor ID
- SCC_002
- Keywords
- squamous cell cancer, skin cancer, non-melanoma skin cancer, squamous cell carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Center for Biomedical Research, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label pilot study
| Arm | Type | Receives |
|---|---|---|
| 30% Ascorbic Acid in DMSO | Experimental | Drug: 30% ascorbic acid in DMSOTopical application twice daily of 300ul 30% (w/v) solution of ascorbic acid in DMSO |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 30% ascorbic acid in DMSOsee above | Drug | 30% Ascorbic Acid in DMSO |
Primary outcome
Lesion Resolution
Time frame: 8 weeks
Number of lesions tumor free by 2 mm punch biopsy post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 30% ascorbic acid in DMSO in people with Squamous Cell Cancer and Squamous Cell Carcinoma, run by Center for Biomedical Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion Resolution (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.