NCT04279535

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

February 19, 2020

Last Update Submit

October 26, 2021

Conditions

Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Lesion Resolution

    Number of lesions resolved out of total of 6 treated.

    8 weeks

Study Arms (2)

ascorbic acid

EXPERIMENTAL

Participants applied topical solution of ascorbic acid twice daily for 8 weeks

Drug: Topical Ascorbic Acid

Imiquimod

ACTIVE COMPARATOR

Participants applied 5% imiquimod cream topically 5x/week

Drug: Topical Ascorbic Acid

Interventions

Topical Ascorbic AcidDRUG

Twice daily application of 300 microliters of 30% ascorbic acid solution with a small cuticle brush.

Imiquimodascorbic acid

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of biopsy proven basal cell carcinoma

You may not qualify if:

  • Absence of basal cell carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Biomedical Research,Inc.

Boise, Idaho, 83706, United States

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Briant Burke, MD

    CBR,Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2020

First Posted

February 21, 2020

Study Start

March 1, 2018

Primary Completion

March 1, 2019

Study Completion

June 1, 2019

Last Updated

November 2, 2021

Record last verified: 2021-10

Locations

US(1)