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Efficacy of Laser Hair Removal Therapy in HS (HaLa)

Primary Purpose

Hidradenitis Suppurativa, Acne Inversa

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nd:YAG laser hair removal
Clindamycin 1 % Topical Lotion
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hidradenitis Suppurativa, Acne Inversa focused on measuring laser hair removal therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention group, laser hair removal therapy

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

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    Difference in IHS4 over time, measured between month 7 to month 12
    The IHS4 will be assessed monthly.

    Secondary Outcome Measures

    Cumulative IHS4 over month 7 to month 12 between the two groups
    IHS4 will be calculated on a monthly bases. IHS4 will be added up per visit which makes it a cumulative outcome
    Change in skin related pain of the axillae, on a numerical rating scale (NRS), between baseline and month 12, and between groups.
    NRS pain will be assessed
    Change in skin related itch of the axillae, on a NRS, between baseline and month 12, and between groups.
    NRS itch will be assessed
    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
    Number of self reported flares will be assessed
    Difference and change in quality of life measured with the Dermatologic Life Quality Index (DLQI) between baseline and month 12 and between groups.
    PROM will be assessed
    Difference and change in quality of life measured with the Hidradenitis Suppurativa Quality of Life score (HiSQOL), between baseline and month 12 and between groups.
    PROM will be assessed
    Difference in patients satisfaction score at month 12 between groups.
    patients satisfaction will be assessed
    Cumulative IHS4 over month 7 to 12, correlated to hair loss after six months.
    the amount of hair loss will be assessed and correlated to the cumulative IHS4
    Cumulative IHS4 calculated over a time period of 3, 9 and 12 months between groups.
    The cumulative IHS4 will be assessed after 3, 9 and 12 months
    Difference in pustule and papule count during visits over month 1 to 12 between groups.
    the number of papules and pustules will be assessed
    Difference in (cumulative) abscess en nodule count over month 1 to 12 between groups.
    number of abscesses and nodules will be assessed
    Difference in number of times escape medication has been used over month 1 to 12 between groups.
    Number of escape medication will be assessed
    Difference of average duration of a flare, reported by the patient, over month 1 to 12 between groups.
    Duration of a flare will be assessed
    The difference in IHS4 and HS-PGA, measured every visit.
    The IHS4 and HS-PGA will be assessed
    Amount of clindamycin lotion use for both groups.
    clindamycin 1% lotion will be weighted every visit
    Difference in number of adverse events between groups.
    safety will be assessed using adverse events
    Incidence and severity of all adverse events (according to medDRA) will be analysed throughout the study.
    safety will be assessed using adverse events
    Histopathological: diameter hair shaft in axillary skin before and after treatment.
    Biopsies will be taken for histopathological research
    Histopathological: plugging of the hair follicle in the skin before and after treatment
    Biopsies will be taken for histopathological research
    Histopathological: immunohistochemistry in the skin before and after treatment
    Biopsies will be taken for histopathological research
    Histopathological: AMP expression in the skin before and after treatment
    Biopsies will be taken for histopathological research

    Full Information

    First Posted
    December 23, 2022
    Last Updated
    February 28, 2023
    Sponsor
    Erasmus Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05762484
    Brief Title
    Efficacy of Laser Hair Removal Therapy in HS
    Acronym
    HaLa
    Official Title
    The Efficacy of Laser Hair Removal Therapy in Patients With Mild to Moderate HS, a Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    April 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Erasmus Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hidradenitis Suppurativa, Acne Inversa
    Keywords
    laser hair removal therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    RCT with intervention and control group
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    58 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group, laser hair removal therapy
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group, clindamycin 1% lotion if needed, standard care
    Arm Type
    Active Comparator
    Arm Description
    Patients will use clindamycin 1% lotion of needed for 1 year.
    Intervention Type
    Procedure
    Intervention Name(s)
    Nd:YAG laser hair removal
    Intervention Description
    Using the Nd:YAG laser (cynergy), hair of the axillae will be removed.
    Intervention Type
    Drug
    Intervention Name(s)
    Clindamycin 1 % Topical Lotion
    Intervention Description
    Clindamycin 1% lotion if needed
    Primary Outcome Measure Information:
    Title
    Difference in IHS4 over time, measured between month 7 to month 12
    Description
    The IHS4 will be assessed monthly.
    Time Frame
    between month 7 to 12
    Secondary Outcome Measure Information:
    Title
    Cumulative IHS4 over month 7 to month 12 between the two groups
    Description
    IHS4 will be calculated on a monthly bases. IHS4 will be added up per visit which makes it a cumulative outcome
    Time Frame
    month 7 to 12
    Title
    Change in skin related pain of the axillae, on a numerical rating scale (NRS), between baseline and month 12, and between groups.
    Description
    NRS pain will be assessed
    Time Frame
    every month for 12 months
    Title
    Change in skin related itch of the axillae, on a NRS, between baseline and month 12, and between groups.
    Description
    NRS itch will be assessed
    Time Frame
    every month for 12 months
    Title
    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
    Description
    Number of self reported flares will be assessed
    Time Frame
    every month for 12
    Title
    Difference and change in quality of life measured with the Dermatologic Life Quality Index (DLQI) between baseline and month 12 and between groups.
    Description
    PROM will be assessed
    Time Frame
    every month for 12 months
    Title
    Difference and change in quality of life measured with the Hidradenitis Suppurativa Quality of Life score (HiSQOL), between baseline and month 12 and between groups.
    Description
    PROM will be assessed
    Time Frame
    every month for 12 months
    Title
    Difference in patients satisfaction score at month 12 between groups.
    Description
    patients satisfaction will be assessed
    Time Frame
    every month for 12 months
    Title
    Cumulative IHS4 over month 7 to 12, correlated to hair loss after six months.
    Description
    the amount of hair loss will be assessed and correlated to the cumulative IHS4
    Time Frame
    every month for 12 months
    Title
    Cumulative IHS4 calculated over a time period of 3, 9 and 12 months between groups.
    Description
    The cumulative IHS4 will be assessed after 3, 9 and 12 months
    Time Frame
    every month for 12 months
    Title
    Difference in pustule and papule count during visits over month 1 to 12 between groups.
    Description
    the number of papules and pustules will be assessed
    Time Frame
    every month for 12 months
    Title
    Difference in (cumulative) abscess en nodule count over month 1 to 12 between groups.
    Description
    number of abscesses and nodules will be assessed
    Time Frame
    every month for 12 months
    Title
    Difference in number of times escape medication has been used over month 1 to 12 between groups.
    Description
    Number of escape medication will be assessed
    Time Frame
    every month for 12months
    Title
    Difference of average duration of a flare, reported by the patient, over month 1 to 12 between groups.
    Description
    Duration of a flare will be assessed
    Time Frame
    every month for 12 months
    Title
    The difference in IHS4 and HS-PGA, measured every visit.
    Description
    The IHS4 and HS-PGA will be assessed
    Time Frame
    every month for 12 months
    Title
    Amount of clindamycin lotion use for both groups.
    Description
    clindamycin 1% lotion will be weighted every visit
    Time Frame
    every month for 12 months
    Title
    Difference in number of adverse events between groups.
    Description
    safety will be assessed using adverse events
    Time Frame
    every month for 12 months
    Title
    Incidence and severity of all adverse events (according to medDRA) will be analysed throughout the study.
    Description
    safety will be assessed using adverse events
    Time Frame
    every month for 12 months
    Title
    Histopathological: diameter hair shaft in axillary skin before and after treatment.
    Description
    Biopsies will be taken for histopathological research
    Time Frame
    Measured at baseline (month 1), after laser hair removal therapy (month 7) and six months after laser hair removal therapy (month 12), for the intervention group
    Title
    Histopathological: plugging of the hair follicle in the skin before and after treatment
    Description
    Biopsies will be taken for histopathological research
    Time Frame
    Measured at baseline (month 1), after laser hair removal therapy (month 7) and six months after laser hair removal therapy (month 12), for the intervention group
    Title
    Histopathological: immunohistochemistry in the skin before and after treatment
    Description
    Biopsies will be taken for histopathological research
    Time Frame
    Measured at baseline (month 1), after laser hair removal therapy (month 7) and six months after laser hair removal therapy (month 12), for the intervention group
    Title
    Histopathological: AMP expression in the skin before and after treatment
    Description
    Biopsies will be taken for histopathological research
    Time Frame
    Measured at baseline (month 1), after laser hair removal therapy (month 7) and six months after laser hair removal therapy (month 12), for the intervention group

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hessel van der Zee, MD, PhD
    Phone
    +31 10 704 0110
    Email
    h.vanderzee@erasmusmc.nl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hessel van der Zee, MD, PhD
    Organizational Affiliation
    Erasmus Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Efficacy of Laser Hair Removal Therapy in HS

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