Actinic Keratosis (AK) Clinical Trial
Official title:
Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalp
This is a phase 4, multi-centre, randomized, two group, open label, active controlled, parallel group, 17 week trial.
All subjects who qualify for this trial are to have 4 to 8 clinically typical, visible and
discrete AK lesions within a contiguous 25 cm2 treatment area on the face or scalp.
Eligible subjects will be randomised in a 1:1 ratio to the following treatment groups:
- Treatment Group A: Ingenol mebutate gel 0.015%, once daily for 3 consecutive days for
the first treatment course. At 8 weeks after treatment initiation, subjects who present
with existing AKs or newly emergent AKs in the treatment area will receive one more
treatment course of ingenol mebutate gel 0.015%, daily for 3 consecutive days.
- Treatment Group B: Diclofenac sodium gel 3%, (0.5 grams), twice daily for 90 days.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01926496 -
Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%
|
Phase 4 | |
| Completed |
NCT03116698 -
A Study to Evaluate Two Concentrations of DFD-07 Cream, in Subjects With Actinic Keratosis (AK) of the Face and/or Scalp Over a 12-week Treatment Period
|
Phase 2/Phase 3 | |
| Completed |
NCT03727074 -
Bioequivalence Study to Compare Sol-Gel Technologies' 5-FU Cream With Efudex® (5-FU) Cream
|
Phase 3 |