Actinic KeratosesTAKKOHNCT04024579
Treatment of Actinic Keratosis With 5% KOH Solution
An observational study of Actinic Keratoses, run by Infectopharm Arzneimittel GmbH at 6 sites in Germany.
Trial summary
This is a prospective single-arm multicenter medical device study to investigate the clinical efficacy and safety of the treatment of actinic keratosis with a 5% potassium hydroxide solution. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Actinic Keratoses
- How many people
- 73 participants
- Where
- 6 sitesGermany
- Study dates
- 17 Oct 2017to 25 Aug 2019
- Phase
- Observational
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients of the participating study sites (medical practice and experienced in the management and treatment of patients suffering from the disease as mentioned in the inclusion criterion), who fulfill all inclusion criteria and do not fulfill any of the exclusion criteria, are eligible for participation in the TAKKOH study
Who may be able to join
- Written informed consent
- Age: 30 to 80 years
- Adults with AK grade I (mild) or II (moderate)
Who cannot join
- Number of lesions requiring treatment > 10
- Lesion to be treated > 20 mm (maximum diameter)
- Lesions directly adjoining to the eyes, eyelids, nostrils, mouth or mucosal tissue,
- Need for topical treatment of a cancerous area
- Presence of a relapsing, persistent, indurated, thickened, painful, bleeding, ulcerated and/or rapidly growing lesion
- Presence of a persistent or relapsing lesion despite appropriate treatment with AKOHDerm or another appropriate treatment
Show all 21Show fewer
- High risk of progression of AK according as assessed by a medical doctor
- Pharmacological or physical local therapy of AK in the area foreseen for treatment dur-ing the last 12 weeks
- Treatment with systemic corticosteroids during the last 2 weeks
- Planned concomitant treatment of the same AK lesions during the study in addition to study treatment
- Other skin diseases in the area of application which might interfere with clinical signs
- Known predisposition for hypertrophic scarring / keloidosis
- Primary or secondary immunodeficiency
- Treatment with interferons, interferon inducers or immunomodulators during the last 4 weeks
- Pregnancy and lactation
- No reliable contraception in women of child-bearing potential
- Other serious diseases which are according to the investigator in conflict with the par-ticipation
- Obvious unreliability or lack of cooperation - known addiction to alcohol, medicinal products or drugs
- Dependent relationship with sponsor or investigator
- Participation in a clinical trial within the last 30 days
- Previous participation in this study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Dermatologisches Zentrum
Bonn, 53111
Hautzentrum Dülmen
Dülmen, 48249
Hautärztliche Praxis
Friedrichshafen, 88045
Hautzentrum Nymphenburg
München, 80639
Haut- und Laserzentrum Potsdam
Potsdam, 14469
Hautarzt-Praxis
Stuttgart, 70190
About this study
Official title: Prospective, Single-arm, Medical Device Investigation According to § 23b MPG [German Medical Devices Act] on Efficacy and Safety of Treatment of Actinic Keratosis With a 5% Potassium Hydroxide Solution (AKOHDerm)
This is a prospective single-arm multicenter medical device study to investigate the clinical efficacy and safety of the treatment of actinic keratosis with a 5% potassium hydroxide solution.
In total, 68 patients with actinic keratosis grade I/II, who meet all inclusion criteria and do not meet none of the exclusion criteria are to be enrolled and topically treated twice daily for up to 3 cycles of 14 days of treatment followed by 14 non-treatment days.
Read more
The primary objective is treatment success at the individual end-of-treatment visit of all AK lesions present at baseline and treated with the investigational product.
Beside this, adverse events will be collected at each visit and evaluated in order to investigate clinical safety.
- Conditions
- Actinic Keratoses
- Medical subject headings
- Keratosis, Actinic
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy (Patients with treatment success): defined as dermatoscopically confirmed complete remission of all AK lesions by the investigator
Treatment success (yes, no) at the individual end-of-treatment visit (VE), defined as dermatoscopically confirmed complete remission of all AK lesions by the investigator, which were present at V0 and treated with the investigational product (complete clearance).
Measured: Visit 14 days after EOT (End of treatment); up to 12 weeks depending treatment cycles nessesary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start17 Oct 2017
- Primary completion25 Aug 2019
- Study completion25 Aug 2019
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infectopharm Arzneimittel GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gesellschaft für Therapieforschung mbH
- Responsible party
- Sponsor
- Investigators
- Dietrich Abeck, Prof., Principal investigator, Professor of dermatology and allergology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024579
- Sponsor's protocol ID
- TAKKOH
- Acronym
- TAKKOH
- Status last verified
- Oct 2019
- First submitted
- 16 Jul 2019
- Last updated
- 22 Oct 2019
- 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 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-arm, Medical Device Investigation According to § 23b MPG [German Medical Devices Act] on Efficacy and Safety of Treatment of Actinic Keratosis With a 5% Potassium Hydroxide Solution (AKOHDerm)
- ClinicalTrials.gov ID
- NCT04024579
- Acronym / sponsor ID
- TAKKOH / TAKKOH
- Conditions
- Actinic Keratoses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Infectopharm Arzneimittel GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Gesellschaft für Therapieforschung mbH
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 25 Aug 2019 (actual)
- Study completion
- 25 Aug 2019 (actual)
- First posted
- 18 Jul 2019 (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 is a prospective single-arm multicenter medical device study to investigate the clinical efficacy and safety of the treatment of actinic keratosis with a 5% potassium hydroxide solution.
In total, 68 patients with actinic keratosis grade I/II, who meet all inclusion criteria and do not meet none of the exclusion criteria are to be enrolled and topically treated twice daily for up to 3 cycles of 14 days of treatment followed by 14 non-treatment days.
The primary objective is treatment success at the individual end-of-treatment visit of all AK lesions present at baseline and treated with the investigational product.
Beside this, adverse events will be collected at each visit and evaluated in order to investigate clinical safety.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients of the participating study sites (medical practice and experienced in the management and treatment of patients suffering from the disease as mentioned in the inclusion criterion), who fulfill all inclusion criteria and do not fulfill any of the exclusion criteria, are eligible for participation in the TAKKOH study
Key inclusion criteria (3 listed)
- Written informed consent
- Age: 30 to 80 years
- Adults with AK grade I (mild) or II (moderate)
Key exclusion criteria (21 listed)
- Number of lesions requiring treatment > 10
- Lesion to be treated > 20 mm (maximum diameter)
- Lesions directly adjoining to the eyes, eyelids, nostrils, mouth or mucosal tissue,
- Need for topical treatment of a cancerous area
- Presence of a relapsing, persistent, indurated, thickened, painful, bleeding, ulcerated and/or rapidly growing lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy (Patients with treatment success): defined as dermatoscopically confirmed complete remission of all AK lesions by the investigator
Time frame: Visit 14 days after EOT (End of treatment); up to 12 weeks depending treatment cycles nessesary
Treatment success (yes, no) at the individual end-of-treatment visit (VE), defined as dermatoscopically confirmed complete remission of all AK lesions by the investigator, which were present at V0 and treated with the investigational product (complete clearance).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
Related trials for Actinic Keratoses
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 4
Cryotherapy in Combination With Red Light PDT for Actinic Keratosis of Full Face
Actinic Keratoses
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.
Dietrich Abeck, Prof. principal investigator
Professor of dermatology and allergology
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Actinic Keratoses, run by Infectopharm Arzneimittel GmbH at 6 sites 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 21 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: finished, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (Patients with treatment success): defined as dermatoscopically confirmed complete remission of all AK lesions by the investigator (time frame: Visit 14 days after EOT (End of treatment); up to 12 weeks depending treatment cycles nessesary). 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 Oct 2019.