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Study on the Effectiveness of 5% Potassium Hydroxide Solution for Treating Mild to Moderate Actinic Keratosis in Adults

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of actinic keratosis, a skin condition that often appears as rough, scaly patches on sun-exposed areas of the skin. The study will compare the effectiveness and safety of a treatment using a 5% solution of potassium hydroxide, known as Solcera, against a placebo. The main goal is to determine if Solcera is more effective in treating mild to moderate cases of actinic keratosis.

Participants in the study will be randomly assigned to receive either the Solcera solution or a placebo. The treatment will be applied topically, meaning it will be put directly on the skin. The study will be conducted in multiple stages, and participants will be monitored throughout the treatment cycles to assess the clearance of actinic keratosis lesions. The study will evaluate the success of the treatment by checking if the skin lesions have completely cleared up after the treatment period.

The trial will also look at other factors, such as the overall condition of the skin over time, any side effects experienced, and the participants' and investigators' assessments of the treatment's effectiveness and tolerability. The study aims to provide valuable information on the potential benefits of using Solcera for treating actinic keratosis, with the hope of offering a more effective treatment option for those affected by this skin condition.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on age and the presence of actinic keratosis lesions. Written consent is required.

  2. Step 2

    Treatment phase 1

    The treatment involves applying a 5% potassium hydroxide solution called Solcera to the affected skin areas. This is a topical solution, meaning it is applied directly to the skin.

    The duration of this phase depends on the response of the lesions to the treatment. The goal is to achieve complete clearance of the lesions.

  3. Step 3

    Control visit after phase 1

    A control visit is conducted to assess the treatment success, defined as complete clearance of the lesions. This is confirmed through a dermatoscopic examination.

  4. Step 4

    Treatment phase 2

    If necessary, a second treatment cycle is initiated. The same 5% potassium hydroxide solution is used.

    The duration of this phase is again dependent on the response of the lesions.

  5. Step 5

    Control visit after phase 2

    Another control visit is conducted to evaluate the success of the second treatment cycle. Complete clearance is assessed.

  6. Step 6

    Treatment phase 3

    A third treatment cycle may be initiated if required. The same solution is applied.

    The duration is based on the lesion response.

  7. Step 7

    Final control visit

    A final control visit is conducted to assess the overall treatment success. Complete clearance of lesions is confirmed.

  8. Step 8

    Follow-up

    A follow-up visit is scheduled to monitor any relapses and assess the long-term success of the treatment.

Who can join the trial?

4 criteria

  • Must be between the ages of 18 and 89 years old.
  • Must have at least one area of skin with actinic keratosis, which is a rough, scaly patch on the skin caused by sun exposure. The severity should be mild or moderate.
  • The affected skin area should be easy for the patient to reach and treat. If not, the patient should have someone available to help with the treatment, who will be trained by the study team.
  • Must provide written consent to participate in the study, meaning you agree to join the study after understanding all the details.

Who cannot join the trial?

7 criteria

  • Patients with any other skin condition that might interfere with the study.
  • Patients who have used any treatment for actinic keratosis in the past 30 days.
  • Patients with a known allergy to any ingredient in the study medication.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients with a history of skin cancer.
  • Patients who are unable to follow the study procedures.
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Investigated drugs

Solcera: This is a 5% potassium hydroxide solution used in the study to treat mild to moderate actinic keratosis. Actinic keratosis is a skin condition caused by sun damage, which can lead to rough, scaly patches on the skin. The solution is applied to the affected areas to help remove these patches and improve the skin's appearance. The study aims to show that this treatment is more effective than a placebo.

What is already known about the treatment

Solcera – This medication is administered as a topical solution, applied directly to the skin. It is currently being studied in clinical trials for its effectiveness in treating mild to moderate actinic keratosis, a skin condition caused by sun damage. Solcera works by using a 5% potassium hydroxide solution to break down the abnormal skin cells, promoting the shedding of these cells and allowing healthier skin to form. It is classified as a topical keratolytic agent, which means it helps to remove the outer layer of the skin.

Investigated diseases

Actinic Keratosis – Actinic keratosis is a skin condition characterized by rough, scaly patches on the skin, primarily caused by prolonged exposure to the sun. These patches often appear on areas such as the face, ears, lips, back of the hands, forearms, scalp, or neck. The condition progresses slowly and can vary in appearance, sometimes becoming red, pink, or brown. Over time, the patches may become thicker and more pronounced. While actinic keratosis itself is not cancer, it can potentially develop into a type of skin cancer called squamous cell carcinoma if left untreated. Regular monitoring and protection from further sun exposure are important to manage the condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514277-21-00Protocol codeKOHPLAKEstimated enrolment630 patientsSponsorINFECTOPHARM Arzneimittel und Consilium GmbH

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