5% KOH solution vs placebo treatment of actinic keratosis with different treatment duration

Overview

Sponsor-declared trial summary

Key facts

Sponsor

INFECTOPHARM Arzneimittel und Consilium GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

19 Mar 2025 → ongoing

Decision date (initial)

2025-01-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

The primary objective of the study is to demonstrate the superiority of the clinical efficacy of solcera (5% potassium hydroxide solution) for mild to moderate actinic keratosis compared to placebo.

Secondary objectives 1

1. Safety of solcera (5% potassium hydroxide solution)

Conditions and MedDRA coding

Actinic keratosis

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Age ≥ 18 years and < 90 years
2. (At least one) palpable and/or clinically/dermatoscopically apparent actinic keratosis (lesion) severity grade I (mild) or II (moderate) according to Olsen
3. Lesion(s) that is/are either easily accessible/treatable by the patient or - in the case of at least one lesion that is difficult to reach - availability of an assistant to be trained by the investigator before the first application of the investigational product, who will take over the treatment for the duration according to the protocol
4. Written informed consent of the patient

Exclusion criteria 26

1. Number of lesions ≥ 6
2. Size of the total lesion area > 25 cm2
3. Lesion diameter > 20 mm (largest diameter)
4. Actinic keratosis (lesion) severity grade III (severe) according to Olsen
5. Lesion in the immediate vicinity of the eyes, nostrils or mouth or mucous membranes, respectively
6. Need for extensive treatment of a cancerized area
7. Presence of a recurrent, persistent, indurated, thickened, painful, bleeding, ulcerating and/or rapidly growing lesion
8. Existing skin cancer (all forms of skin cancer incl. basal cell carcinoma and squamous cell carcinoma) in the area intended for treatment
9. Skin injuries, infected skin areas or dermatitis exfoliativa in the area intended for treatment
10. Other disruptive skin disease in the area intended for treatment
11. Pharmacological or physical local therapy of actinic keratosis (or application of the active substances used for pharmacological therapy) in the area intended for treatment during the last 4 weeks
12. Primary or secondary immunodeficiency
13. Treatment with interferons, interferon inducers, immunomodulators or systemic corticosteroids during the last 4 weeks
14. Treatment with oral isotretinoin in the last 6 months
15. Known tendency to excessive scarring
16. Known intolerance/hypersensitivity to any of the components of the investigational medicinal products, in particular parabens
17. Known serious mental illness or risk of suicide
18. Other serious illnesses which, in the opinion of the investigator, prevent participation
19. Obvious unreliability, unwillingness to cooperate or expected withdrawal of consent
20. Known alcohol, medication or drug addiction
21. Limited legal capacity
22. Court/official order for placement in an institution
23. Dependence on the sponsor or an investigator
24. Participation in a clinical trial in the last 30 days
25. Previous participation in this clinical trial
26. Participation of a relative (in the same household) of the patient in this clinical trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Treatment success of the trial participants (“complete clearance” = complete, dermatoscopically confirmed remission of all actinic keratosis lesions of a trial participant that were present at the start of treatment and treated (with the investigational medicinal product)) at the control visit after the end of treatment (“EOT”, after the end of the off-phase of the 1st, 2nd or 3rd treatment cycle depending on the course of remission), evaluated separately for phase 1, 2 and 3.

Secondary endpoints 15

1. Lesion-related treatment success ("complete remission") of the actinic keratosis lesions (present at the start of treatment and treated (with the investigational medicinal product)), for which a complete remission was documented (at least once) until the end of treatment ("EOT"), evaluated separately for phase 1, 2 and 3
2. Lesion-related treatment success ("complete remission") of the actinic keratosis lesions (present at the start of treatment and treated (with the investigational medicinal product)), for which a complete remission was documented (at least once) until the respective visit, at all visit (except at the end of treatment ("EOT")), evaluated separately for phase 1, 2 and 3
3. Lesion-related treatment success of actinic keratosis lesions (present at the start of treatment and treated (with the investigational medicinal product)) with complete remission taking into account relapses, at all visits, evaluated separately for phase 1, 2 and 3
4. Treatment success ("complete clearance") of the trial participants in relation to actinic keratosis lesions present at the start of treatment and treated (with the investigational medicinal product) and additionally separately in relation to all actinic keratosis lesions (i.e. including actinic keratosis lesions occurring in the treated area after the start of treatment), at all visits, evaluated separately for phase 1, 2 and 3
5. Treatment success of the trial participants without consideration of relapses in relation to actinic keratosis lesions present at the start of treatment and treated (with the investigational medicinal product) and additionally separately in relation to all actinic keratosis lesions (i.e. including actinic keratosis lesions occurring in the treated area after the start of treatment), at all visits, evaluated separately for phase 1, 2 and 3
6. Trial participants with "partial clearance" (at least 75% of actinic keratosis lesions (present at start of treatment and treated (with the investigational medicinal product)) with complete remission), at all visits, evaluated separately for phase 1, 2 and 3
7. Response to therapy: trial participants with at least one actinic keratosis lesion with complete remission, at all visits, evaluated separately for phase 1, 2 and 3
8. Percentage reduction in the number of lesions per trial participant compared to baseline (in relation to actinic keratosis lesions present at the start of treatment and treated (with the investigational medicinal product)), at all visits, evaluated separately for phase 1, 2 and 3
9. Trial participants with relapse: trial participants with relapse occurred after "complete clearance" (at least one actinic keratosis lesion (present at the start of treatment and treated (with the investigational medicinal product)) with relapse assessment), in relation to all trial participants and additionally separately in relation to trial participants with (previous) "complete clearance", in the period up to the follow-up visit, evaluated separately for phase 1, 2 and 3
10. Actinic keratosis lesions with relapse: actinic keratosis lesions (present at the start of treatment and treated (with the investigational medicinal product)) with relapse assessment, in relation to all actinic keratosis lesions and additionally separately in relation to actinic keratosis lesions with (previous) complete remission, in the period up to the follow-up visit, evaluated separately for phase 1, 2 and 3
11. Healing stage/condition of the actinic keratosis lesions over time at all visit, overall and according to localisation and size in relation to actinic keratosis lesions present at the start of treatment and treated (with the investigational medicinal product) and also separately in relation to all actinic keratosis lesions (i.e. including actinic keratosis lesions that occurred in the treated area after the start of treatment), evaluated separately for phase 1, 2 and 3
12. Efficacy, tolerability and overall assessment by the investigator and the trial participant in school grades (1-6, at the end of treatment ("EOT") and at the follow-up visit), evaluated separately for phase 1, 2 and 3
13. Adverse events, serious adverse events, side effects and serious side effects (with separate presentation of local reactions, query "Part of the expected/desired inflammatory reaction?", duration and separately duration in relation to the duration of treatment as well as number and duration after the end of treatment with the investigational medicinal product), evaluated separately for phase 1, 2 and 3
14. Dropouts (with reason for discontinuation and timepoint), evaluated separately for phase 1, 2 and 3
15. Compliance, evaluated separately for phase 1, 2 and 3

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

INFECTOPHARM Arzneimittel und Consilium GmbH

Sponsor organisation

INFECTOPHARM Arzneimittel und Consilium GmbH

Address

Von-Humboldt-Strasse 1

City

Heppenheim (Bergstrasse)

Postcode

64646

Country

Germany

Scientific contact point

Organisation

INFECTOPHARM Arzneimittel und Consilium GmbH

Contact name

Tanja Wehran

Public contact point

Organisation

INFECTOPHARM Arzneimittel und Consilium GmbH

Contact name

Tanja Wehran

Third parties 1

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 20 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications