BridgeMD
New treatment option for Actinic Keratosis of Face and Scalp
Official title Phase 3 - Evaluation of Veregen® 10% Ointment as New Herbal Topical Treatment for Actinic Keratosis
ClinicalTrials.gov ID: NCT07137819
What this study is testing
What is Topical treatment?
Topical treatment is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for actinic keratosis of face and scalp.
Also referred to as Veregen 10% ointment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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)...
- 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...
- AK lesions of the TA must be clinically typical AK lesions of Olsen grade I and/or grade Olsen grade II.
You likely can't join 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...
- 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.
See the full eligibility criteria
- 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.
- 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...
- 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...
- 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)...
- 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 treatment 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Strausberg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Strausberg, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.