Clinical trial · Interventional
Bioequivalence Study to Compare Sol-Gel Technologies' 5-FU Cream With Efudex® (5-FU) Cream
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Bioequivalence Study to Compare Sol-Gel Technologies' 5-FU Cream, With Efudex® (5-FU) Cream, and Both Active Treatments to a Vehicle Control, in the Treatment of Actinic Keratosis
NCT03727074CI-TRIAL-00044104completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To compare the relative efficacy and safety and of 5-FU Cream to the marketed formulation Efudex® (5-FU) Cream, and to demonstrate the superior efficacy of the two active formulations over that of the Vehicle Control Cream, in the treatment of actinic keratosis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis (AK) | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU Cream | Drug | Fluorouracil | ALIAS |
| Efudex® | Drug | Fluorouracil | ALIAS |
| Vehicle | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 5-FU Cream
- description
- topical cream
- interventionNames
- Drug: 5-FU Cream
- type
- ACTIVE_COMPARATOR
- label
- Efudex®
- description
- topical cream
- interventionNames
- Drug: Efudex®
- type
- PLACEBO_COMPARATOR
- label
- Vehicle
- description
- topical cream
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male and female 18 years of age and older. 2. Subject is able to understand and willing to sign Institutional Review Board (IRB) approved written informed consent for this study. 3. Subject must be generally healthy, based on medical records, and free from any clinically significant disease, other than AK, that in the opinion of the investigator might interfere with the study evaluations. 4. At least five (5) and no more than ten (10) clinically typical, visible or palpable, discrete AK lesions, each at least 4 mm in diameter on the face (excluding ears), forehead or bald scalp. Exclusion Criteria: 1. Subject is pregnant, lactating, or is planning a pregnancy within the period of study participation. 2. Subject suffers from excessive alcohol consumption, drug abuse or has a condition that could compromise the subject's ability to comply with study requirements. 3. Presence of Atopic Dermatitis, Basal Cell Carcinoma, Eczema, Psoriasis, Rosacea, Squamous Cell Carcinoma or other possible confounding skin conditions on the
References
Publications (0)
Data not yet available
No reference posted for this study.