Efficacy of Laser Hair Removal Therapy in HS

NCT05762484 | Not Yet Recruiting

• 1 other identifier: EMCD_22026
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hidradenitis Suppurativa, Acne Inversa

Keywords

laser hair removal therapy

Outcome Measures

Primary Outcomes (1)

• Difference in IHS4 over time, measured between month 7 to month 12

  The IHS4 will be assessed monthly.

  between month 7 to 12

Secondary Outcomes (21)

• Cumulative IHS4 over month 7 to month 12 between the two groups

  month 7 to 12

• Change in skin related pain of the axillae, on a numerical rating scale (NRS), between baseline and month 12, and between groups.

  every month for 12 months

• Change in skin related itch of the axillae, on a NRS, between baseline and month 12, and between groups.

  every month for 12 months

• Difference in number of self-reported flares (number of flares reported by the patients in the last 4 weeks), between the two groups during this study

  every month for 12

• Difference and change in quality of life measured with the Dermatologic Life Quality Index (DLQI) between baseline and month 12 and between groups.

  every month for 12 months

Study Arms (2)

Intervention group, laser hair removal therapy

EXPERIMENTAL

Patients will undergo 6 monthly laser hair removal treatments with de Nd:YAG laser. After 6 months, a 6 follow up will start, using clindamycin 1% lotion if needed.

Procedure: Nd:YAG laser hair removal

Control group, clindamycin 1% lotion if needed, standard care

ACTIVE COMPARATOR

Patients will use clindamycin 1% lotion of needed for 1 year.

Drug: Clindamycin 1 % Topical Lotion

Interventions

Nd:YAG laser hair removal PROCEDURE

Using the Nd:YAG laser (cynergy), hair of the axillae will be removed.

Intervention group, laser hair removal therapy

Clindamycin 1 % Topical Lotion DRUG

Clindamycin 1% lotion if needed

Control group, clindamycin 1% lotion if needed, standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• IHS4 mild to moderate, without tunnels in the axillae.
• HS activity in at least one axilla.
• Age 18 years and over.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Clindamycin

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Hessel van der Zee, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hessel van der Zee, MD, PhD

CONTACT

+31 10 704 0110; h.vanderzee@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: RCT with intervention and control group

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: March 9, 2023
• Study Start: April 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: April 1, 2026
• Last Updated: March 9, 2023

Record last verified: 2023-02