D23.9
Conditions
Interventions
Group 1: excision by scissors
We will use both treatment methods on each subject. We will always start with the left side of the body (neck or armpits). The randomised allocation of which procedure w
Sponsors
Praxis Prof. Dr. Krengel/Dr. Mrowka/Dr. Haase
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The clinical diagnosis is clearly fibromata pendulantia. 2. The patient is at least 18 years old. 3. The patient should be under sixty so that no high-risk patients have to be called into the doctor's office in times of the COVID-19 pandemic. 4. The patient is able to understand and sign the patient information sheet and informed consent form. 5. The patient is able to follow all study instructions and attend all study appointments. 6. The patient is not pregnant and does not breastfeed. 7. The patient is in good general health and is free from disease or physical complaints, e.g. other skin diseases, which, in the opinion of the investigator, might interfere with the evaluation of a target lesion or would expose the subject to unacceptable risk by participating in the study.
Exclusion criteria
Exclusion criteria: 1. The patient is pregnant and/or breastfeeding. 2. The patient is younger than 18 and older than 59 years. 3. The patient has mental retardation, dementia and/or requires a legal guardian. 4. The patient is not willing to abstain from unprotected sunbathing or tanning. 5. The patient has a flurid or uncontrolled skin condition in the study area (e.g. psoriasis, eczema, or a skin condition (sunburn) that, in the opinion of the investigator, would endanger the patient if he/she participated in the study or could interfere with the study procedure. 6. Severe coagulation disorders; ASA and Marcumar use are not exclusion criteria, Factor Xa antagonists can be paused 24 h before treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hypothesis: Treatment by the 532 nm LBO laser shows the highest acceptance among the subjects ("Which procedure would you prefer if you were treated again?"). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The treatment with scissors is more painful than the treatment with the LBO laser. 2. The subjects find it an advantage that there is no bleeding with laser therapy and no bandages are needed. 3. The laser therapy causes less pigment displacement and scars. The cosmetic result is objectively better after 3 months. | — |
Countries
Germany
Contacts
Public ContactCharlotte Winkelmann-Schirmer
Hautpartner
Outcome results
None listed