An Early Phase 1 interventional study of 30% ascorbic acid in DMSO in Squamous Cell Cancer, Squamous Cell Carcinoma and Skin Cancer, sponsored by Center for Biomedical Research, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-30.
Sponsored by Center for Biomedical Research, Inc. · Early Phase 1, Interventional, and Treatment
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.
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.
627 studies on the registry are indexed under Carcinoma, Squamous Cell; 133 are open to participants now.
This study's planned enrollment of 15 is below the median of 45 across 476 interventional studies indexed under Carcinoma, Squamous Cell.
Browse Carcinoma, Squamous Cell studies →Center for Biomedical Research, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Compared within Carcinoma, Squamous Cell, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms, Squamous Cell. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inclusion Criteria: Presence of proven squamous cell cancer of the skin -
Exclusion Criteria: Previous history of , diabetes,
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Topical application twice daily of 300ul 30% (w/v) solution of ascorbic acid in DMSO
Drug: 30% ascorbic acid in DMSO
see above
Lesion Resolution
Number of lesions tumor free by 2 mm punch biopsy post treatment
Time frame: 8 weeks
Started Jun 2023 (actual). Primary completion is estimated for Dec 2024, 18 months after the start.
Of 42 phase 1 interventional studies under Carcinoma, Squamous Cell, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 62. This study's planned 18 months is below that.
How these figures are worked out, and which studies are left out of them.
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Center for Biomedical Research, Inc.