NCT05932511

Brief 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. Outcome measure was biopsy proven resolution of the carcinoma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

1.6 years

First QC Date

June 21, 2023

Last Update Submit

August 28, 2023

Conditions

Squamous Cell CancerSquamous Cell CarcinomaSkin CancerNon-melanoma Skin Cancer

Keywords

squamous cell cancerskin cancernon-melanoma skin cancersquamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • Lesion Resolution

    Number of lesions tumor free by 2 mm punch biopsy post treatment

    8 weeks

Study Arms (1)

30% Ascorbic Acid in DMSO

EXPERIMENTAL

Topical application twice daily of 300ul 30% (w/v) solution of ascorbic acid in DMSO

Drug: 30% ascorbic acid in DMSO

Interventions

30% ascorbic acid in DMSODRUG

see above

30% Ascorbic Acid in DMSO

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Biomedical Research,Inc.

Boise, Idaho, 83706, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms, Squamous CellCarcinoma, Squamous CellSkin Neoplasms

Interventions

Ascorbic AcidDimethyl Sulfoxide

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsCarcinomaNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesSulfoxidesSulfur Compounds

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open label pilot study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2023

First Posted

July 6, 2023

Study Start

June 12, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

US(1)