Phase 3 - Evaluation of Veregen® 10% Ointment as New Herbal Topical Treatment for Actinic Keratosis
NCT07137819 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280
Last updated 2025-08-22
Summary
The goal of this clinical trial is to show superiority of Veregen® 10% ointment to Placebo measured by complete (100%) clearance of a pre-defined treatment area (TA) following a treatment period of 12 weeks and a 4-weeks post-treatment (PT) period (i.e., after 16 weeks at most in patients without complete clearance at the end of the treatment (EoT) period).
Conditions
- Actinic Keratosis of Face and Scalp
Interventions
- DRUG
-
Topical treatment
Self-treatment of patients with ointment of a pre-defined treatment area (TA) following a treatment period of 12 weeks and a 4-weeks post-treatment (PT) period (i.e., after 16 weeks at most in patients without complete clearance at the end of the treatment (EoT) period).
Sponsors & Collaborators
-
Aresus Pharma GmbH
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-04
- Primary Completion
- 2026-03-31
- Completion
- 2027-11-30
Countries
- Germany
Study Locations
More Related Trials
-
A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)
NCT03285490 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomized, Vehicle-Controlled Study of 2 Concentrations of A-101 for the Treatment of Seborrheic Keratosis
NCT03148691 ·Status: COMPLETED ·Phase: PHASE2
-
The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses
NCT00786994 ·Status: COMPLETED ·Phase: PHASE2
-
A Multicenter Study to Evaluate the Safety and Efficacy of PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
NCT00700063 ·Status: COMPLETED ·Phase: PHASE2
-
Activity & Safety Study of KX2-391 Ointment in Participants With Actinic Keratosis on the Face or Scalp
NCT02838628 ·Status: COMPLETED ·Phase: PHASE2
-
A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp
NCT03285477 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis
NCT05279131 ·Status: COMPLETED ·Phase: PHASE3
-
Multiple-dose Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis
NCT02559934 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety Phase II Study of SR-T100 to Treat Actinic Keratosis
NCT01516515 ·Status: COMPLETED ·Phase: PHASE2
-
Phase I/IIa Trial to Evaluate AVX001 Gel in Doses of 1% or 3% Compared With Vehicle Over Four Weeks of Field-directed Treatment Period in Adult Subjects With AK
NCT05164393 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Dose-finding, Safety, Efficacy Trial of Topical Resiquimod in Patients With Multiple Actinic Keratosis Lesions
NCT01583816 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up
NCT02547233 ·Status: COMPLETED ·Phase: PHASE3
-
Ph 1, Single-Center, Safety, Tolerability & Pharmacokinetic Study of KX2 391 Ointment in Subj. w Actinic Keratosis
NCT02337205 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy Study & Safety Evaluation of SR-T100 Gel in Actinic Keratosis Treatment
NCT01493921 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of the Efficacy and Tolerability of Solaraze for 3 Versus 6 Months in Patients With Mild to Moderate Actinic Keratosis Located on the Face and Head
NCT00204542 ·Status: COMPLETED ·Phase: PHASE4
-
Double-blind, Randomized, Vehicle- and Comparator-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of LAS41007 in the Treatment of Actinic Keratosis
NCT01265602 ·Status: COMPLETED ·Phase: PHASE3
-
Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis
NCT06319794 ·Status: COMPLETED ·Phase: PHASE2
-
Study of A-101 for the Treatment of Seborrheic Keratosis
NCT02260180 ·Status: COMPLETED ·Phase: PHASE2
-
Single-Center Study Evaluating Systemic Exposure and Safety of KX2-391 Ointment 1% on the Face or Balding Scalp in Subjects With Actinic Keratosis
NCT03575780 ·Status: COMPLETED ·Phase: PHASE1
-
A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze® Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald Scalp
NCT02611804 ·Status: COMPLETED ·Phase: PHASE3
-
Earliest Stage Treatment of Aktinic Keratosis With Imiquimod 3.75% Cream
NCT04842422 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis
NCT01820260 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
PRO With Luxerm® in the Field Treatment of Thin and Non-hyperkeratotic Non-pigmented AK
NCT03511326 ·Status: COMPLETED ·Phase: PHASE4
-
Pharmacokinetic Study of Solamargine in Patients With Actinic Keratosis
NCT02029066 ·Status: COMPLETED ·Phase: PHASE1
-
A Multi-Center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
NCT00915551 ·Status: COMPLETED ·Phase: PHASE3