Actinic Keratosis of Face and ScalpPhase 3EXACT-1NCT07137819
Phase 3 - Evaluation of Veregen® 10% Ointment as New Herbal Topical Treatment for Actinic Keratosis
A Phase 3 study testing Topical treatment in people with Actinic Keratosis of Face and Scalp, run by Aresus Pharma GmbH at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis of Face and Scalp
- What is being tested?
- Topical treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteGermany
- Study dates
- 4 Sep 2024to Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
- Current or planned application of dermal preparations with astringent effect on the TA, such as zinc paste or tannin-containing ointments/creams
- Patients taking a drug with known potential for skin reactions must have taken it at a stable dose for at least 2 weeks prior to Baseline, except in cases where no previous skin reactions have occurred at any dose.
- Women of childbearing potential (WOCBP) will not be considered unless they use a highly effective method of contraception (failure rate of less than 1% per year) during the interventional period until 4-weeks PT (EoI, V9).
- Within the TA, any suspicion of other malignant or benign skin tumors.
- History of a genetic skin-cancer disorder (e.g. xeroderma pigmentosum) and/or invasive tumor in the TA, such as a Merkel cell tumor, an invasive spinocellular carcinoma or a BCC (Basal Cell Carcinoma) and/or any skin cancer (suspected or diagnosed recently or within 5 years ago before screening).
- History or evidence of skin conditions other than AK that would interfere with evaluation of the study medication (e.g. eczema, unstable psoriasis).
- Patients having any significant physical abnormalities in the TA that may cause difficulty with examination or AK assessments (e.g. tattoes, scars, hyperpigmentation, etc.).
- Evidence of clinically significant or unstable medical conditions such as: (a) metastatic tumor or tumor with high probability of metastatic spread, (b) heart failure (NYHA class III or higher), (c) immunosuppressive disorder (e.g. HIV, organ transplant patients), (d) hematologic, hepatic, renal, neurologic or endocrine disorder, (e) collagen-vascular disorder (e.g. cerebro-vascular or other bleeding disorder), (f) gastrointestinal disorder (e.g. active ulcera or history of recurrent peptic ulcera or hemorrhage).
- Patients not willing to stop using skin care products (e.g. self-tanning products, sunscreens, make-ups/colored day care cremes, topical treatments with anti-aging products, vitamin A, vitamin C, and/or vitamin E containing ointments and gels) in the TA during the interventional period of the study (i.e., during the treatment and until 4 weeks post-treatment).
- Patients not willing to stop any use of make-ups colored day care cremes, and sunscreens in the treatment area within 12 hours prior to an on-site visit during the PTFU period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Adaptive Phase 3 Study to Evaluate the Efficacy and Safety of Sinecatechins (Defined Extract of Green Tea Leaves) Ointment in Adult Patients With Actinic Keratosis of the Scalp and the Face
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).
Read the detailed description
Participants type: Patients Age range: 18-64 years, 65+ years; male and female Locations: Germany
- Conditions
- Actinic Keratosis of Face and Scalp
- Being tested
- Topical treatment
- Keywords
- Veregen® 10% ointment, Actinic Keratosis (AK) of the Scalp and/or the Face, Germany, Sinecatechins, Green tea
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical treatmentDrug
Also called Veregen 10% ointment
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Topical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of treatment period at 12 weeks and a 4-weeks post-treatment (PT) period (i.e., after 16 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start4 Sep 2024
- Primary completionMar 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic Keratosis of Face and ScalpStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The primary objective of the study is to show superiority of Veregen® 10% ointment to Placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aresus Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137819
- Sponsor's protocol ID
- 2022-502811-12-00 - Pro_VER-01
- Other IDs
- 2022-502811-12-00
- Acronym
- EXACT-1
- Status last verified
- Jul 2025
- First submitted
- 15 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Adaptive Phase 3 Study to Evaluate the Efficacy and Safety of Sinecatechins (Defined Extract of Green Tea Leaves) Ointment in Adult Patients With Actinic Keratosis of the Scalp and the Face
- ClinicalTrials.gov ID
- NCT07137819
- Acronym / sponsor ID
- EXACT-1 / 2022-502811-12-00 - Pro_VER-01
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Aresus Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Participants type: Patients Age range: 18-64 years, 65+ years; male and female Locations: Germany
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The primary objective of the study is to show superiority of Veregen® 10% ointment to Placebo.
| Arm | Type | Receives |
|---|---|---|
| Verum arm using Veregen® 10% ointment | Experimental | Drug: Topical treatmentThis 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). |
| Placebo arm using placebo to Veregen® 10% ointment | Placebo comparator | Drug: Topical treatmentThis 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical treatmentAlso: Veregen 10% ointmentSelf-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). | Drug | Placebo arm using placebo to Veregen® 10% ointment, Verum arm using Veregen® 10% ointment |
Primary outcome
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.
Time frame: From enrollment to the end of treatment period at 12 weeks and a 4-weeks post-treatment (PT) period (i.e., after 16 weeks).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topical treatment in people with Actinic Keratosis of Face and Scalp, run by Aresus Pharma GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sven Schimansky-Wabra, Managing Director (004933415899040, exact-1@aresus.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From enrollment to the end of treatment period at 12 weeks and a 4-weeks post-treatment (PT) period (i.e., after 16 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.