Phase 3 - Evaluation of Veregen® 10% Ointment as New Herbal Topical Treatment for Actinic Keratosis

NCT07137819 | Recruiting Phase 3 DMC

• 2 other identifiers: 2022-502811-12-00 - Pro_VER-012022-502811-12-00
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Veregen® 10% ointment; Actinic Keratosis (AK) of the Scalp and/or the Face; Germany; Sinecatechins; Green tea

Outcome Measures

Primary Outcomes (1)

• Primary objective 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.

  The primary objective of the study 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).

  From enrollment to the end of treatment period at 12 weeks and a 4-weeks post-treatment (PT) period (i.e., after 16 weeks).

Study Arms (2)

Verum arm using Veregen® 10% ointment

EXPERIMENTAL

This arm uses Veregen® 10% ointment to measure 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).

Drug: Topical treatment

Placebo arm using placebo to Veregen® 10% ointment

PLACEBO COMPARATOR

This arm uses placebo ointment for self-treatment of patients in 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).

Drug: Topical treatment

Interventions

Topical treatment DRUG

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).

Also known as: Veregen 10% ointment

Placebo arm using placebo to Veregen® 10% ointment; Verum arm using Veregen® 10% ointment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients willing to participate, obtained written informed consent.
• Male or female patients ≥ 18 years.
• Clinically confirmed diagnosis of mild to moderate Actinic keratosis (AK) of the face including the forehead (excluding eyelids, lips and mucosa) and/or the bald scalp.
• Presence of at least 4 but not more than 8 isolated (i.e. discrete and quantifiable) AK lesions located in a contiguous treatment area (TA) on the face and/or bald scalp of 25 square-cm.
• AK lesions of the TA must be clinically typical AK lesions of Olsen grade I and/or grade Olsen grade II.
• Ability to follow study instructions and likely to complete all study requirements.

You may not qualify if:

• TA is within 5 cm of an incompletely healed wound or infected area of the skin.
• Patients not willing to abstain from sunbathing (including solarium) or any outdoor activities with intensive sun exposure without taking appropriate measures to protect the treatment areas during the study.
• Patients with a tendency to manipulate skin parts e.g. scratching.
• Pregnant or breast-feeding patients.
• Patients currently or within the past 4 weeks participating in another clinical study.
• Any previous randomization into this clinical study.
• Any suspicion of current drug and/or alcohol abuse.
• Patient is institutionalized because of legal or regulatory order.
• Dependency (as an employee or relative) to the sponsor/responsible CRO or investigator.
• Any condition that in the opinion of the investigator can influence the evaluation of the treatment, and other assessments.
• Hypersensitivity, intolerance or allergies against ingredients of Veregen® 10% ointment and/or Placebo ointment.
• AK lesions in the TA with atypical clinical appearance (e.g. TA contains massively hyperkeratotic and hypertrohic lesions (Olsen grade III AK), recalcitrant lesions, cutaneous horns, and/or lesions that had not responded to 2 previous cryotherapies).
• Have received the following topical or physical treatments for any indication in the treatment area within the designated time period before treatment with study drug: a) Curettage, Photodynamic therapy, Topical inhibitors of Src tyrosine kinase signaling and tubulin polymerization (e.g.,Tirbanibulin) for/in a period of 12 weeks; b) Topical retinoids, Topical diclofenac preparations, Topical 5-fluorouracil preparations, Topical immunomodulators (e.g., Imiquimod) for/in a period of 6 weeks; c) Topical steroids, Cryo-, thermo- or chemodestruction, Surgical excision for/in a period of 4 weeks.
• Initiation of treatment with the following systemic treatments for any indication within 2 weeks before Baseline: Immunomodulators or immunosuppressive therapies, Diclofenac, Corticosteroids (oral or injectable), Inhaled corticosteroids (\>1200 µg/day for beclomethasone, or \>600 µg/day for fluticasone)
• Current or planned intake of high dosed oral green tea preparations for any reason

Sponsors & Collaborators

• Aresus Pharma GmbH: lead

Study Sites (1)

Aresus Pharma GmbH

Strausberg, Germany

RECRUITING

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Therapeutics; green tea extract polyphenone E; Ointments

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Sven Schimansky-Wabra, Managing Director

CONTACT

004933415899040; exact-1@aresus.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The primary objective of the study is to show superiority of Veregen® 10% ointment to Placebo.

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 22, 2025
• Study Start: September 4, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-07

Locations

DE (1)