Actinic KeratosesNCT06274320
Effect of Lipikar Urea 30% Before Actinic Keratoses Treatment
A study testing Group A: holistic approach and Group B: Tolak® Standard of use in people with Actinic Keratoses, run by Cosmetique Active International at 1 site in Germany.
Trial summary
This study is conducted in one center in Germany, in adult subjects having actinic keratoses (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria. The purpose of the study is to evaluate a holistic management (efficacy, tolerability and lesion cosmetic outcomes) of Tolak® treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- Group A: holistic approach and Group B: Tolak® Standard of use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 5 Apr 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosis of at least 4 non-hypertrophic, non-hyperkeratotic actinic keratosis of the the scalp
- planned treatment of actinic keratoses of the scalp with Tolak®
- Olsen grade I or II
Who cannot join
- known or documented intolerance to any of the ingredients of Tolak® or Lipikar Urea 30%
- treatment of actinic keratoses in the treatment area within the past 3 months (e.g. photodynamic therapy, topical 5-FU, diclofenac, imiquimod, cryotherapy etc.)
- suspected invasive squamous cell cancer in the treatment area
- chronic wounds, erosions, pre-existing inflamed or infected skin with disruption of the epidermal barrier in the treatment area current or within the last 8 weeks given systemic cancer medication or systemic treatment with 5-Fluorouracil
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of a 2 Weeks Lipikar Urea 30% Application Preceding a Planned Topical 5-FU 4% Actinic Keratoses Treatment on Efficacy of 5-FU 4%
This study is conducted in one center in Germany, in adult subjects having actinic keratoses (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria. The purpose of the study is to evaluate a holistic management (efficacy, tolerability and lesion cosmetic outcomes) of Tolak® treatment.
Read the detailed description
Actinic keratoses (AK) are chronic skin changes usually induced by UV radiation. There are numerous options to treat AK. Some of the most used field-directed therapies include topical therapy with 5-fluorouracil (5-FU) cream and photodynamic therapy. However, the treatment with 5-FU is not without side effects (erythema, pruritus, itching/burning, etc.). Therefore, in daily clinical practice, cosmetic pre- and concomitant applications of cosmetics are often recommended to increase the efficacy as well as the tolerability of Tolak®.
The aim of this randomized, evaluator blinded, controlled parallel group study conducted in compliance with the 2013 version of the Declaration of Helsinki is to determine whether and how the application of cosmetics leads to an influence on the microbiome of AK.
Statistical method: The variables will be analyzed by using the Cochran-Mantel-Haenszel (CMH) statistic, after ridit transformation with the row mean difference statistics, testing the hypothesis of equality. Each test will be two-sided, at the 0.050 significance level.
- Conditions
- Actinic Keratoses
- Being tested
- Group A: holistic approach, Group B: Tolak® Standard of use
- Keywords
- actinic keratoses, Lipikar Urea 30%, Olsen grade
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A: holistic approachOther
2-week Lipikar Urea 30% application (once daily in the evening) + 4-week Tolak® treatment (once daily in the evening)
Group B: Tolak® Standard of useOther
4-week Tolak® alone treatment (once daily in the evening)
| Study group | Role | What they receive |
|---|---|---|
| Group A: holistic approach | Experimental | adult subjects having AK (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria including a Tolak® treatment planned before study start Receives: Other: Group A: holistic approach |
| Group B: Tolak® Standard of use | Active comparator | adult subjects having AK (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria including a Tolak® treatment planned before study start Receives: Other: Group B: Tolak® Standard of use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lesion response rate
It is defined as the number of completely responding lesions divided by the total number of treated lesions in each field. Complete lesion response is defined as complete disappearance of the lesion both by palpation and visual.
Measured: from baseline to Day70
Secondary outcomes (1)
Percentage change
The lesion complete response rate is defined as the percentage of pre-existing and treated lesions at Baseline that are assessed as clear (complete disappearance of the lesion, visually and by palpation).
Measured: from baseline to Day70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start5 Apr 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosesStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Dirschka, Principal investigator, CentroDerm GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274320
- Sponsor's protocol ID
- LRP22002 LIPIKAR UREA 30%
- Status last verified
- Jun 2024
- First submitted
- 16 Feb 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of a 2 Weeks Lipikar Urea 30% Application Preceding a Planned Topical 5-FU 4% Actinic Keratoses Treatment on Efficacy of 5-FU 4%
- ClinicalTrials.gov ID
- NCT06274320
- Acronym / sponsor ID
- LRP22002 LIPIKAR UREA 30%
- Conditions
- Actinic Keratoses
- Keywords
- actinic keratoses, Lipikar Urea 30%, Olsen grade
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 23 Feb 2024 (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.
This study is conducted in one center in Germany, in adult subjects having actinic keratoses (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria. The purpose of the study is to evaluate a holistic management (efficacy, tolerability and lesion cosmetic outcomes) of Tolak® treatment.
Detailed description
Actinic keratoses (AK) are chronic skin changes usually induced by UV radiation. There are numerous options to treat AK. Some of the most used field-directed therapies include topical therapy with 5-fluorouracil (5-FU) cream and photodynamic therapy. However, the treatment with 5-FU is not without side effects (erythema, pruritus, itching/burning, etc.). Therefore, in daily clinical practice, cosmetic pre- and concomitant applications of cosmetics are often recommended to increase the efficacy as well as the tolerability of Tolak®.
The aim of this randomized, evaluator blinded, controlled parallel group study conducted in compliance with the 2013 version of the Declaration of Helsinki is to determine whether and how the application of cosmetics leads to an influence on the microbiome of AK.
Statistical method: The variables will be analyzed by using the Cochran-Mantel-Haenszel (CMH) statistic, after ridit transformation with the row mean difference statistics, testing the hypothesis of equality. Each test will be two-sided, at the 0.050 significance level.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: holistic approach | Experimental | Other: Group A: holistic approachadult subjects having AK (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria including a Tolak® treatment planned before study start |
| Group B: Tolak® Standard of use | Active comparator | Other: Group B: Tolak® Standard of useadult subjects having AK (grade I or II) lesions on the scalp and meeting specific inclusion/exclusion criteria including a Tolak® treatment planned before study start |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of at least 4 non-hypertrophic, non-hyperkeratotic actinic keratosis of the the scalp
- planned treatment of actinic keratoses of the scalp with Tolak®
- Olsen grade I or II
Key exclusion criteria (4 listed)
- known or documented intolerance to any of the ingredients of Tolak® or Lipikar Urea 30%
- treatment of actinic keratoses in the treatment area within the past 3 months (e.g. photodynamic therapy, topical 5-FU, diclofenac, imiquimod, cryotherapy etc.)
- suspected invasive squamous cell cancer in the treatment area
- chronic wounds, erosions, pre-existing inflamed or infected skin with disruption of the epidermal barrier in the treatment area current or within the last 8 weeks given systemic cancer medication or systemic treatment with 5-Fluorouracil
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 |
|---|---|---|
| Group A: holistic approach2-week Lipikar Urea 30% application (once daily in the evening) + 4-week Tolak® treatment (once daily in the evening) | Other | Group A: holistic approach |
| Group B: Tolak® Standard of use4-week Tolak® alone treatment (once daily in the evening) | Other | Group B: Tolak® Standard of use |
Primary outcome
Change in lesion response rate
Time frame: from baseline to Day70
It is defined as the number of completely responding lesions divided by the total number of treated lesions in each field. Complete lesion response is defined as complete disappearance of the lesion both by palpation and visual.
1 secondary outcome
Percentage change
Time frame: from baseline to Day70
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
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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. This study is not recruiting at the moment.
Thomas Dirschka principal investigator
CentroDerm GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A: holistic approach and Group B: Tolak® Standard of use in people with Actinic Keratoses, run by Cosmetique Active International 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Jun 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Dirschka (+49 2 02 / 629337-32, s.weber@centroderm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lesion response rate (time frame: from baseline to Day70). 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 18 Jun 2024.