What is Veregen 10% ointment studying for Actinic Keratosis?

Veregen 10% ointment is being studied to see if it can completely clear Actinic Keratosis lesions on the face and scalp better than a placebo ointment. This trial helps understand if this herbal topical treatment is effective for patients with mild to moderate AK. The study is sponsored by Aresus Pharma GmbH.

Who may be eligible for this Actinic Keratosis clinical trial?

Adults 18 years or older with a clinical diagnosis of mild to moderate Actinic Keratosis on the face or bald scalp may be eligible. Both men and women can participate if they have 4 to 8 isolated AK lesions in a specific treatment area and can follow study instructions. Please review eligibility criteria for more details.

Is there any cost to participate in this Actinic Keratosis clinical trial?

Study-related care, including the study ointment and all trial visits, is provided at no cost. Personal expenses for travel or other costs may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID07137819

Phase 3 Study to Test Veregen40 10% Ointment as a New Herbal Treatment for Actinic Keratosis on the Face and Scalp

Led by Aresus Pharma GmbH · Updated on 2025-08-22

280

Participants Needed

Research Sites

87 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating Veregen 10% ointment as a new herbal topical treatment for adults with mild to moderate Actinic Keratosis AK on the face and scalp. The study aims to show that Veregen ointment is superior to a placebo ointment in completely clearing a defined treatment area of AK lesions. This randomized, placebo-controlled, double-blind Phase 3 trial focuses on patients aged 18 and older with specific AK lesion characteristics.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patients willing to participate and able to give written informed consent
Male or female patients aged 18 years or older
Clinically confirmed mild to moderate Actinic Keratosis of the face (excluding eyelids, lips, and mucosa) and/or bald scalp
Presence of 4 to 8 isolated AK lesions within a contiguous 25 square-centimeter treatment area on the face and/or bald scalp
AK lesions of Olsen grade I or II only
Ability to follow study instructions and complete all study requirements

You will not qualify if you...

Treatment area within 5 cm of an incompletely healed wound or infected skin
Unwillingness to avoid sunbathing or intense sun exposure without protection during the study
Tendency to manipulate skin such as scratching
Pregnant or breastfeeding
Participation in another clinical study currently or within past 4 weeks
Previous randomization in this study
Suspicion of current drug or alcohol abuse
Institutionalized by legal or regulatory order
Dependency on sponsor, CRO, or investigator
Conditions affecting treatment evaluation
Allergies or intolerance to ingredients of Veregen 10% ointment or placebo
Presence of atypical or severely thickened AK lesions (Olsen grade III) or recalcitrant lesions
Recent topical or physical treatments in the area within specified timeframes
Recent systemic treatments like immunomodulators or corticosteroids within 2 weeks before baseline
Current or planned use of high-dose oral green tea preparations
Use of dermal astringent preparations on treatment area
Use of drugs with potential skin reactions not stable for at least 2 weeks before baseline
Women of childbearing potential not using effective contraception during study and 4 weeks post-treatment
Suspicion of other malignant or benign skin tumors in treatment area
History of genetic skin-cancer disorders or invasive tumors in treatment area
Skin conditions interfering with evaluation (e.g., eczema, unstable psoriasis)
Significant physical abnormalities in treatment area affecting assessments
Unstable or significant medical conditions such as metastatic tumors, severe heart failure, immunosuppressive disorders, or bleeding disorders
Unwillingness to stop use of skin care products in treatment area during study
Unwillingness to avoid makeup, colored day care creams, or sunscreens within 12 hours of on-site visits during follow-up period

Research Team

Sven Schimansky-Wabra, Managing Director

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Phase 3 Study to Test Veregen40 10% Ointment as a New Herbal Treatment for Actinic Keratosis on the Face and Scalp

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria