Actinic KeratosisPhase 3KOHDIAKNCT04552327
5% KOH Solution vs. Placebo and Diclofenac Gel for the Treatment of Actinic Keratosis
A Phase 3 study testing Solcera and Solaraze in people with Actinic Keratosis, run by Infectopharm Arzneimittel GmbH at 18 sites in Germany.
Trial summary
The KOHDIAK study is a prospective, three-armed, randomised, double-blind study to evaluate the efficacy and safety of the treatment of mild and moderate actinic keratosis with a 5% potassium hydroxide solution (Solcera, medical device) versus placebo and investigator-blinded comparison with 3% diclofenac gel… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Solcera and Solaraze
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 631 participants
- Where
- 18 sitesGermany
- Study dates
- 14 Oct 2020to 24 Jan 2023
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and < 90 years
- Actinic keratosis grade I (mild) or II (moderate) according to the definition by Olsen with palpable or clinically/dermatoscopically apparent keratosis
- Either lesions being well accessible/treatable by the patient or presence of a second person to do the daily applications
- Written informed consent by the patient
Who cannot join
- Number of initial lesions to be treated ≥ 6
- Overall size of the area to be treated > 25 cm2
- Size (maximum diameter) of single lesion to be treated > 20 mm
- Lesions in close proximity to the eyes, eyelids, nostrils, mouth or mucosal tissue
- Need for topical treatment of cancerous area
- Presence of a relapsing, persistent, indurated, thickened, painful, bleeding, ulcerated and/or rapidly growing lesion
Show all 24Show fewer
- Existing skin cancer (all forms of skin cancer incl. basal-cell carcinoma and squamous cell carcinoma) in the area to be treated in this study
- Dermal injuries, skin infection or exfoliative dermatitis in the area to be treated in this study
- Other skin diseases in the area to be treated in this study that affect the diagnostic assessment
- Pharmacological or physical local therapy of actinic keratosis (or application of the active ingredients used in the pharmacological therapy) in the area to be treated in this study during the last 4 weeks
- Primary or secondary immunodeficiency
- Treatment with interferons, interferon inducers, immunomodulators or systemic corticosteroids during the last 4 weeks
- Treatment with oral isotretinoin during the last 6 months
- Intracranial bleeding in the medical history or generally increased primary bleeding tendency
- Known intolerance/hypersensitivity to one of the ingredients of the investigational products, especially to diclofenac, parabens or benzyl alcohol as well as to NSAIDs, in particular acetylsalicylic acid
- Pregnancy and lactation
- Women of child-bearing potential either wishing to become pregnant or without effective contraception
- Other serious diseases, which are (according to the investigator's assessment) in conflict with the study participation (i.a. also in view of risk factors for a severe course of a potential COVID-19 disease in case of a SARS-CoV-2 infection)
- Obvious unreliability or lack of cooperation
- Known addiction to alcohol, medicinal products or drugs
- Dependency on the sponsor or an investigator
- Participation in a clinical trial during the last 30 days
- Previous participation in the present clinical trial
- Participation of a family member (in the same household) in the present clinical trial
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Germany18 sites
Hautmedizin Bad Soden
Bad Soden, 65812
MVZ - Dermatologisches Zentrum Bonn GmbH
Bonn, 53111
Hautzentrum Köln
Cologne, 50996
Proderma Studienzentrum
Dülmen
Hautarztpraxis Falkensee
Falkensee, 14612
Hautzentrum Südbaden
Freiburg im Breisgau
Hautarztzentrum Hamm
Hamm
Praxis Dres. Med. Markus Kaspari und Florian Schenk
Hanover, 30159
Durani Cosmetics GmbH
Heidelberg
Hautarztpraxis Ibbenbüren
Ibbenbueren
Praxis Dres. K.-H. Vehring/U. Amann
Lingen, 49809
Zentderma GBR
Mönchengladbach, 41061
Haut- und Laserzentrum
Potsdam
Hautarztpraxis Asefi/Sadjadi
Simmern
Hautarztpraxis Leitz und Kollegen
Stuttgart
Hautarztpraxis Vilshofen
Vilshofen, 94474
Centroderm GmbH
Wuppertal, 42287
Hautzentrum Wuppertal
Wuppertal, 42349
About this study
Official title: Prospective, Three-armed, Randomised, Double-blind Study to Evaluate the Efficacy and Safety of the Treatment of Mild and Moderate Actinic Keratosis With a 5% Potassium Hydroxide Solution (Solcera, Medical Device) Versus Placebo and Investigator-blinded Comparison With 3% Diclofenac Gel (Solaraze, Medicinal Product) (Regulated by the Laws for Both Medical Devices and Medicinal Products)
The KOHDIAK study is a prospective, three-armed, randomised, double-blind study to evaluate the efficacy and safety of the treatment of mild and moderate actinic keratosis with a 5% potassium hydroxide solution (Solcera, medical device) versus placebo and investigator-blinded comparison with 3% diclofenac gel (Solaraze, medicinal product). It is performed in accordance with both the laws in force for clinical trials with medical devices and those with medicinal products.
- Conditions
- Actinic Keratosis
- Being tested
- Solcera, Placebo, Solaraze
- Keywords
- Actinic Keratosis, Solcera, Prospective, Multicentric, Monitored, Efficacy, Safety, Potassium Hydroxide, Randomized, Double-Blind
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SolceraDevice
Twice daily application for a duration of 4 weeks followed by another 4 weeks without treatment (up to 2 potential repetitions of this 8-week cycle)
PlaceboDevice
Twice daily application for a duration of 4 weeks followed by another 4 weeks without treatment (up to 2 potential repetitions of this 8-week cycle)
SolarazeDrug
Twice daily application for a duration of 60 days
| Study group | Role | What they receive |
|---|---|---|
| Solcera | Experimental | Not described Receives: Device: Solcera |
| Placebo | Placebo comparator | Not described Receives: Device: Placebo |
| Solaraze | Active comparator | Not described Receives: Drug: Solaraze |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success
Treatment success, defined as complete, dermatoscopically confirmed remission of all initial actinic keratosis (AK) lesions identified at treatment start that have been treated with the investigational product ("Complete Clearance")
Measured: At the control visit at the end of treatment ("EOT", i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60)
Secondary outcomes (21)
Treatment success
Treatment success, defined as complete, dermatoscopically confirmed remission of all initial AK lesions identified at treatment start that have been treated with the investigational product ("Complete Clearance")
Measured: For Solaraze at day 90
(Healing) status of AK lesions
(Healing) status of AK lesions (number of proliferating lesions, unchanged/stable lesions, lesions being in remission or showing partial remission, lesions with complete remission, and relapses; overall and grouped by localisation and size (0-5 mm, 6-10 mm, 11-15 mm, 16-20 mm)); analysed for a) initial AK lesions identified at treatment start that have been treated with the investigational product, b) new AK lesions appearing in the treated area after treatment start, c) all AK lesions (i.e. a) + b))
Measured: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Overall number of AK lesions
Overall number of initial AK lesions identified at treatment start that have been treated with the investigational product (i.e. without AK lesions with complete remission)
Measured: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Mean size of AK lesions
Mean size of initial AK lesions identified at treatment start that have been treated with the investigational product (lesion size determined by largest diameter)
Measured: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Treatment success
Treatment success (complete, dermatoscopically confirmed remission of lesions) analysed for a) initial AK lesions identified at treatment start that have been treated with the investigational product, b) new AK lesions appearing in the treated area after treatment start, c) all AK lesions (i.e. a) + b))
Measured: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Partial clearance
Number of patients with "partial clearance" (i.e. all patients with at least 75% of the initial AK lesions identified at treatment start being assessed with "complete remission")
Measured: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Reduction of AK lesion number
Reduction of AK lesion number per patient (in % compared to the number of initial AK lesions identified at treatment start) analysed for initial AK lesions identified at treatment start that have been treated with the investigational product
Measured: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Clinical response
Clinical response, i.e. the number of patients with at least one AK lesion being assessed with "complete remission"
Measured: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Lesion-based treatment success (without consideration of relapses)
Number of initial AK lesions identified at treatment start that have been treated with the investigational product, which showed "complete remission" at least once between treatment start and EOT
Measured: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Lesion-based treatment success (with consideration of relapses)
Number of initial AK lesions identified at treatment start that have been treated with the investigational product, which showed "complete remission" at the respectively analysed visit
Measured: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Patients with relapse
Number of patients with at least one initial AK lesion being assessed as "relapse" after previous "Complete Clearance" (definition see above), analysed for the time period between treatment start and the follow-up visit after 24 weeks and analysed in reference to a) the number of all patients and b) the number of those patients with previous "Complete Clearance"
Measured: Analysed at the follow-up visit 24 weeks after treatment start for the time period between treatment start and the follow-up visit
Lesions with relapse
Number of initial AK lesions being assessed as "relapse", analysed for the time period between treatment start and the follow-up visit after 24 weeks and analysed in reference to a) the number of all initial lesions and b) the number of those initial lesions with previous "complete remission"
Measured: Analysed at the follow-up visit 24 weeks after treatment start for the time period between treatment start and the follow-up visit
Efficacy assessment by physician
Assessment of the efficacy (scale based on school grades 1-6) by the treating physician
Measured: At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
Efficacy assessment by patient
Assessment of the efficacy (scale based on school grades 1-6) by the patient
Measured: At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
Tolerability assessment by physician
Assessment of the tolerability (scale based on school grades 1-6) by the treating physician
Measured: At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
Tolerability assessment by patient
Assessment of the tolerability (scale based on school grades 1-6) by the patient
Measured: At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
Overall assessment by physician
Overall assessment (scale based on school grades 1-6) by the treating physician
Measured: At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
Overall assessment by patient
Overall assessment (scale based on school grades 1-6) by the patient
Measured: At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
Adverse Events, Serious Adverse Events, Adverse Reactions
Number and frequency of Adverse Events, Serious Adverse Events and Adverse Reactions
Measured: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
Dropouts
All dropouts (incl. specification of reason and date)
Measured: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
Compliance
Compliance of the patients with the application schedule of the respective investigational product (based on entries in the patient diary and only overruled by the weight of returned investigational products in case of clear discrepancies)
Measured: Analysed for the respective time period of scheduled product application, i.e. Day 0 until Day 60 for Solaraze and 1-3x 28 days (depeding on number of cycles) for Solcera/Placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start14 Oct 2020
- Primary completion24 Jan 2023
- Study completion24 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosisStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 631 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
- Uwe Reinhold, Prof., Study director, MVZ - Dermatologisches Zentrum Bonn GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552327
- Sponsor's protocol ID
- KOHDIAK
- Acronym
- KOHDIAK
- Status last verified
- Feb 2024
- First submitted
- 3 Sep 2020
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reinhold U, Leitz N, Dominicus R, Szabo EL, Dirschka T, Popp G, Fischer TC, Adamini N, Ostendorf R, Asefi M, Durani H, Holting T, Amann U, Kreuziger F, Assmann T, Bruning H, Freitag L, Hoffmann K, Gedschold R. KOH 5% solution versus diclofenac 3% for the treatment of actinic keratosis - Results from a three-armed RCT. J Eur Acad Dermatol Venereol. 2026 Jun;40(6):1050-1058. doi: 10.1111/jdv.70069. Epub 2025 Sep 25.
PubMed 40996107
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Three-armed, Randomised, Double-blind Study to Evaluate the Efficacy and Safety of the Treatment of Mild and Moderate Actinic Keratosis With a 5% Potassium Hydroxide Solution (Solcera, Medical Device) Versus Placebo and Investigator-blinded Comparison With 3% Diclofenac Gel (Solaraze, Medicinal Product) (Regulated by the Laws for Both Medical Devices and Medicinal Products)
- ClinicalTrials.gov ID
- NCT04552327
- Acronym / sponsor ID
- KOHDIAK / KOHDIAK
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis, Solcera, Prospective, Multicentric, Monitored, Efficacy, Safety, Potassium Hydroxide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 631 participants (actual)
- Lead sponsor
- Infectopharm Arzneimittel GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Gesellschaft für Therapieforschung mbH
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 24 Jan 2023 (actual)
- Study completion
- 24 Jan 2023 (actual)
- First posted
- 17 Sep 2020 (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 KOHDIAK study is a prospective, three-armed, randomised, double-blind study to evaluate the efficacy and safety of the treatment of mild and moderate actinic keratosis with a 5% potassium hydroxide solution (Solcera, medical device) versus placebo and investigator-blinded comparison with 3% diclofenac gel (Solaraze, medicinal product). It is performed in accordance with both the laws in force for clinical trials with medical devices and those with medicinal products.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Solcera | Experimental | Device: Solcera |
| Placebo | Placebo comparator | Device: Placebo |
| Solaraze | Active comparator | Drug: Solaraze |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years and < 90 years
- Actinic keratosis grade I (mild) or II (moderate) according to the definition by Olsen with palpable or clinically/dermatoscopically apparent keratosis
- Either lesions being well accessible/treatable by the patient or presence of a second person to do the daily applications
- Written informed consent by the patient
Key exclusion criteria (24 listed)
- Number of initial lesions to be treated ≥ 6
- Overall size of the area to be treated > 25 cm2
- Size (maximum diameter) of single lesion to be treated > 20 mm
- Lesions in close proximity to the eyes, eyelids, nostrils, mouth or mucosal tissue
- Need for topical treatment of cancerous area
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 |
|---|---|---|
| SolceraTwice daily application for a duration of 4 weeks followed by another 4 weeks without treatment (up to 2 potential repetitions of this 8-week cycle) | Device | Solcera |
| PlaceboTwice daily application for a duration of 4 weeks followed by another 4 weeks without treatment (up to 2 potential repetitions of this 8-week cycle) | Device | Placebo |
| SolarazeTwice daily application for a duration of 60 days | Drug | Solaraze |
Primary outcome
Treatment success
Time frame: At the control visit at the end of treatment ("EOT", i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60)
Treatment success, defined as complete, dermatoscopically confirmed remission of all initial actinic keratosis (AK) lesions identified at treatment start that have been treated with the investigational product ("Complete Clearance")
21 secondary outcomes
Treatment success
Time frame: For Solaraze at day 90
(Healing) status of AK lesions
Time frame: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Overall number of AK lesions
Time frame: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Mean size of AK lesions
Time frame: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Treatment success
Time frame: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Partial clearance
Time frame: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Reduction of AK lesion number
Time frame: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Clinical response
Time frame: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Lesion-based treatment success (without consideration of relapses)
Time frame: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Lesion-based treatment success (with consideration of relapses)
Time frame: At all control/follow-up visits with evaluation of lesions (i.e. for Solcera/Placebo 8 weeks (+ potentially 16 weeks) and 24 weeks after treatment start; for Solaraze Day 30, Day 60, Day 90, 24 weeks)
Patients with relapse
Time frame: Analysed at the follow-up visit 24 weeks after treatment start for the time period between treatment start and the follow-up visit
Lesions with relapse
Time frame: Analysed at the follow-up visit 24 weeks after treatment start for the time period between treatment start and the follow-up visit
Efficacy assessment by physician
Time frame: At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
Efficacy assessment by patient
Time frame: At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
Tolerability assessment by physician
Time frame: At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
Tolerability assessment by patient
Time frame: At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
Overall assessment by physician
Time frame: At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
Overall assessment by patient
Time frame: At EOT (i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60) and at the follow-up visit 24 weeks after treatment start
Adverse Events, Serious Adverse Events, Adverse Reactions
Time frame: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
Dropouts
Time frame: In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)
Compliance
Time frame: Analysed for the respective time period of scheduled product application, i.e. Day 0 until Day 60 for Solaraze and 1-3x 28 days (depeding on number of cycles) for Solcera/Placebo
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 5 Mar 2024.
- Derived from this study: PubMed 40996107Reinhold U, Leitz N, Dominicus R, Szabo EL, Dirschka T, Popp G, Fischer TC, Adamini N, Ostendorf R, Asefi M, Durani H, Holting T, Amann U, Kreuziger F, Assmann T, Bruning H, Freitag L, Hoffmann K, Gedschold R. KOH 5% solution versus diclofenac 3% for the treatment of actinic keratosis - Results from a three-armed RCT. J Eur Acad Dermatol Venereol. 2026 Jun;40(6):1050-1058. doi: 10.1111/jdv.70069. Epub 2025 Sep 25.
- Individual participant dataSharing planned: No
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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.
Uwe Reinhold, Prof. study director
MVZ - Dermatologisches Zentrum Bonn GmbH
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Solcera and Solaraze in people with Actinic Keratosis, run by Infectopharm Arzneimittel GmbH at 18 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 4 inclusion and 24 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 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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. 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?
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?
Treatment success (time frame: At the control visit at the end of treatment ("EOT", i.e. for Solcera/Placebo at the end of cycle 1, 2 or 3 (each cycle is 56 days, number of cycles depends on course of remission), for Solaraze day 60)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04552327, which also lists 1 linked publication.
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 5 Mar 2024.