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

NCT04552327 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 631

Last updated 2024-03-05

No results posted yet for this study

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.

Conditions

  • Actinic Keratosis

Interventions

DEVICE

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)

DEVICE

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)

DRUG

Solaraze

Twice daily application for a duration of 60 days

Sponsors & Collaborators

  • Gesellschaft für Therapieforschung mbH

    collaborator INDUSTRY

  • Infectopharm Arzneimittel GmbH

    lead INDUSTRY

Principal Investigators

  • Uwe Reinhold, Prof. · MVZ - Dermatologisches Zentrum Bonn GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-14
Primary Completion
2023-01-24
Completion
2023-01-24

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04552327 on ClinicalTrials.gov