Can a wrinkle treatment calm a rare, painful skin disease?
NCT ID NCT02782702
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Hailey-Hailey and Darier disease are rare inherited skin conditions that cause painful, itchy lesions in skin folds. Sweating makes them worse, and standard treatments often do not work well. Researchers are testing whether botulinum toxin injections into large skin folds can reduce sweating and improve patients' quality of life. The trial enrolls 30 adults with moderate to severe lesions and measures changes in a skin-related quality-of-life score over six months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- botulinum toxin injections into large skin folds
- What this could lead to
- If it helps, botulinum toxin injections could become a way to ease the painful, itchy skin lesions these rare conditions cause, especially in hot weather when sweating makes them worse.
- What could go wrong
- This is a small early-stage trial of 30 people, so any benefit may not hold up in larger studies. Botulinum toxin can cause weakness, trouble swallowing, or allergic reactions in some people.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
30 people
The number who actually took part.
- Start date
-
Sep 2015
- Finished
-
Nov 2017
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Confirmed diagnosis (clinical and histological features) of Hailey Hailey or Darier diseases. * Moderate to very severe lesions located in large folds * Patient aged 18 ans or more * Patient with health coverage * Patient who have signed the consent form * Patient proficient into filling out the questionnaires. Exclusion Criteria: * Hypersensibility to toxin or excipients * Myastheny * Deglutition's problems * Past medical history of dysphagia or aspiration pneumonia * Pregnancy (positive B-HCG test performed a maxima 72h before) or breastfeeding * Mental , physical incapacity to fill in the questionnaires * Guardianship patients * Skin infections at the inclusion visit * Application in the last 7 days at the site of injection of local treatments (apart emollients or antiseptics) or injections of botulism toxin or dynamic phototherapy or laser in the last 6 months. * Systemic treatment with aminosides in the last 15 days * Inclusion in another study in the last 2 months.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Darier disease are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Centre Hospitalier Universitaire
Toulouse, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.