Clinical trial

The Efficacy of Laser Hair Removal Therapy in Patients With Mild to Moderate HS, a Randomized Controlled Trial.

Name
EMCD_22026
Description
Hidradenitis suppurativa (HS) is a chronic, recurrent and debilitating inflammatory skin disorder, characterized by painful inflamed nodules, abscesses and tunnels in the skin folds such as the axilla, inguinal region and gluteal area. The primary event in HS is occlusion of the hair follicle. HS is a notoriously difficult to treat disease, because treatment options are limited and evidence based treatments are scarce. Prevention of diseases is an important topic in medicine. However, current clinical trials in HS are focusing on anti-inflammatory drugs in patients with severe HS, whereas prevention and treatment of patients with more common mild HS is neglected. Laser hair removal therapy is a non-invasive procedure with minimal treatment discomfort for patients. Previous limited studies have suggested positive results in favor of laser hair removal therapy in HS. We therefore hypothesize that hair depilation using laser hair removal therapy may prevent the formation of new lesions and flares of the disease. The objective is to assess the efficacy of laser hair removal therapy in patients with mild to moderate HS.
Trial arms
Trial start
2023-04-01
Estimated PCD
2024-12-01
Trial end
2026-04-01
Status
Not yet recruiting
Treatment
Nd:YAG laser hair removal
Using the Nd:YAG laser (cynergy), hair of the axillae will be removed.
Arms:
Intervention group, laser hair removal therapy
Clindamycin 1 % Topical Lotion
Clindamycin 1% lotion if needed
Arms:
Control group, clindamycin 1% lotion if needed, standard care
Size
58
Primary endpoint
Difference in IHS4 over time, measured between month 7 to month 12
between month 7 to 12
Eligibility criteria
Inclusion Criteria: * IHS4 mild to moderate, without tunnels in the axillae. * HS activity in at least one axilla. * Age 18 years and over. Exclusion Criteria: * If the patient is not able or willing to provide informed consent. * If the patient is allergic to clindamycin lotion. * If the patient uses systemic therapy for HS such as antibiotics or biologicals. * If a patient is pregnant.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'RCT with intervention and control group', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 58, 'type': 'ESTIMATED'}}
Updated at
2023-03-09

1 organization

1 product

1 indication