RecruitingRare disease

Study on Botulinum Toxin Type A for Treating Hidradenitis Suppurativa in Patients: A Comparison of Different Drug Combinations

Verified siteRegistered drugNo placebo

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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 effects of a treatment for Hidradenitis Suppurativa, a chronic skin condition that causes small, painful lumps under the skin. The treatment being tested is Botox, which is a form of botulinum toxin type A. Botox is commonly known for its use in cosmetic procedures, but it is also used in various medical treatments. In this study, Botox will be compared to a placebo to evaluate its effectiveness in reducing the symptoms of Hidradenitis Suppurativa.

The purpose of the study is to assess how well Botox can reduce the activity of Hidradenitis Suppurativa over a period of six months. Participants will receive injections of either Botox or a placebo in affected areas of their skin. The study will monitor changes in the severity of the condition using a scoring system called the IHS4 score, which helps measure the treatment's effect. The study will also look at other factors, such as the number of painful lumps, patient satisfaction, and overall quality of life improvements.

Participants in the study will be followed for up to 12 months, with regular check-ups to monitor their progress. The study aims to provide valuable information on whether Botox can be an effective treatment option for people suffering from Hidradenitis Suppurativa, potentially offering relief from the symptoms of this challenging condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm the diagnosis of hidradenitis suppurativa by a dermatologist.
The severity of the condition is evaluated using the Hurley stage system, ensuring that both sides of the body are affected equally.
Step 2
Baseline measurement
The IHS4 score is recorded to establish a baseline for the study. This score helps in assessing the activity of the condition.
The IHS4 score categorizes the condition as mild, moderate, or severe based on specific point ranges.
Step 3
Treatment administration
The treatment involves the injection of botulinum toxin type a and other substances such as sodium chloride.
The injections are administered as a solution for injection at specified intervals, as determined by the study protocol.
Step 4
Follow-up assessments
Regular follow-up assessments are conducted to monitor the reduction in the IHS4 score and other secondary endpoints.
These assessments include evaluating the number of inflammatory and non-inflammatory nodules, as well as patient-reported outcomes such as pain and quality of life.
Step 5
Final evaluation
A final evaluation is conducted six months after the baseline measurement to assess the overall treatment effect.
The primary endpoint is the reduction in the IHS4 score, while secondary endpoints include treatment satisfaction and other quality of life measures.

Who can join the trial?

6 criteria

The patient must have **hidradenitis suppurativa**, a skin condition, affecting both sides of the body equally.
The patient must be receiving treatment at Gentofte Hospital.
The patient must sign an informed consent form before joining the study. This means they agree to participate after understanding the study details.
The patient must have their **hidradenitis suppurativa** diagnosis confirmed by a dermatologist, a doctor who specializes in skin conditions.
The patient must be able to understand and answer questions on their own in the study questionnaires.
The patient must be over 18 years old.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with Hidradenitis Suppurativa cannot participate. Hidradenitis Suppurativa is a skin condition that causes small, painful lumps under the skin.
Patients who are not within the specified age range cannot participate. The study includes certain age groups, so if you are outside these groups, you cannot join.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care, like those with certain disabilities or conditions, are not included.
Patients who do not meet the specific health criteria set by the study cannot participate. This means if your health condition does not match what the study is looking for, you cannot join.

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Verified sites

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Verified
Gentofte Hospital
Hellerup, Denmark

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Investigated drugs

Botox is being studied for its potential to treat patients with Hidradenitis Suppurativa, a chronic skin condition. In this trial, Botox is used to see if it can reduce the activity of the disease. The effectiveness of Botox will be measured by a specific scoring system that evaluates the severity of the condition before and after treatment. The goal is to determine if Botox can help decrease the symptoms and improve the quality of life for patients with this condition.

What is already known about the treatment

Botox – Botox is administered through injections directly into the affected areas of the skin. It is currently being studied for its effectiveness in treating Hidradenitis Suppurativa, a chronic skin condition. The main therapeutic indication for Botox in this context is to reduce the activity of the disease, as measured by a specific scoring system. At the molecular level, Botox works by blocking the release of certain chemicals that signal pain and inflammation, which may help in reducing the symptoms of the condition. It is classified pharmacologically as a neurotoxin, specifically targeting nerve endings to prevent the release of neurotransmitters.

Investigated diseases

Hidradenitis Suppurativa – Hidradenitis Suppurativa is a chronic skin condition characterized by the formation of painful lumps under the skin, typically in areas where skin rubs together, such as the armpits, groin, and under the breasts. These lumps can become inflamed and may rupture, leading to the formation of tunnels under the skin. Over time, the condition can cause scarring and the development of additional lumps. The severity of the disease can vary, with some individuals experiencing mild symptoms and others facing more severe and frequent flare-ups. The progression of the disease often involves cycles of flare-ups and healing, which can significantly impact the quality of life.