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JOURNAL ONKOLOGIE – STUDIE
KOHDIAK

5% KOH Solution vs. Placebo and Diclofenac Gel for the Treatment of Actinic Keratosis

Rekrutierend

NCT-Nummer:
NCT04552327

Studienbeginn:
Oktober 2020

Letztes Update:
12.02.2021

Wirkstoff:
Solaraze

Indikation (Clinical Trials):
Keratosis, Actinic, Keratosis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Infectopharm Arzneimittel GmbH

Collaborator:
Gesellschaft für Therapieforschung mbH

Studienleiter

Uwe Reinhold, Prof.
Study Director
MVZ - Dermatologisches Zentrum Bonn GmbH

Kontakt

Studienlocations
(3 von 17)

Hautmedizin Bad Soden
65812 Bad Soden
(Hessen)
GermanyRekrutierend» Google-Maps
Hautarztpraxis Falkensee
14612 Falkensee
(Brandenburg)
GermanyNoch nicht rekrutierend» Google-Maps
Praxis Dres. Med. Markus Kaspari und Florian Schenk
30159 Hannover
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Hautzentrum Köln
50996 Köln
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Praxis Dres. K.-H. Vehring/U. Amann
49809 Lingen
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Hautarztpraxis Vilshofen
94474 Vilshofen
(Bayern)
GermanyRekrutierend» Google-Maps
Centroderm GmbH
42287 Wuppertal
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief 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 (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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- 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

Studien-Rationale

Primary outcome:

1. 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")



Secondary outcome:

1. Treatment success (Time Frame - For Solaraze at day 90):
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")

2. (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)):
(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))

3. 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)):
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)

4. 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)):
Mean size of initial AK lesions identified at treatment start that have been treated with the investigational product (lesion size determined by largest diameter)

5. 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)):
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))

6. 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)):
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")

7. 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)):
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

8. 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)):
Clinical response, i.e. the number of patients with at least one AK lesion being assessed with "complete remission"

9. 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)):
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

10. 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)):
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

11. 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):
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"

12. 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):
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"

13. 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):
Assessment of the efficacy (scale based on school grades 1-6) by the treating physician

14. 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):
Assessment of the efficacy (scale based on school grades 1-6) by the patient

15. 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):
Assessment of the tolerability (scale based on school grades 1-6) by the treating physician

16. 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):
Assessment of the tolerability (scale based on school grades 1-6) by the patient

17. 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 (scale based on school grades 1-6) by the treating physician

18. 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):
Overall assessment (scale based on school grades 1-6) by the patient

19. 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)):
Number and frequency of Adverse Events, Serious Adverse Events and Adverse Reactions

20. Dropouts (Time Frame - In the time period between start of treatment and the follow-up visit (24 weeks after treatment start)):
All dropouts (incl. specification of reason and date)

21. 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):
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)

Studien-Arme

  • Experimental: Solcera
  • Placebo Comparator: Placebo
  • Active Comparator: Solaraze

Geprüfte Regime

  • Solcera:
    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)
  • Placebo:
    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)
  • Solaraze:
    Twice daily application for a duration of 60 days

Quelle: ClinicalTrials.gov


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