Efficacy of Laser Hair Removal Therapy in HS (HaLa)

February 28, 2023 updated by: Hessel H van der Zee, MD, PhD, Erasmus Medical Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group, laser hair removal therapy
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
Using the Nd:YAG laser (cynergy), hair of the axillae will be removed.
Active Comparator: Control group, clindamycin 1% lotion if needed, standard care
Patients will use clindamycin 1% lotion of needed for 1 year.
Drug: Clindamycin 1 % Topical Lotion
Clindamycin 1% lotion if needed

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in IHS4 over time, measured between month 7 to month 12
Time Frame: between month 7 to 12
The IHS4 will be assessed monthly.
between month 7 to 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cumulative IHS4 over month 7 to month 12 between the two groups
Time Frame: month 7 to 12
IHS4 will be calculated on a monthly bases. IHS4 will be added up per visit which makes it a cumulative outcome
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.
Time Frame: every month for 12 months
NRS pain will be assessed
every month for 12 months
Change in skin related itch of the axillae, on a NRS, between baseline and month 12, and between groups.
Time Frame: every month for 12 months
NRS itch will be assessed
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
Time Frame: every month for 12
Number of self reported flares will be assessed
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.
Time Frame: every month for 12 months
PROM will be assessed
every month for 12 months
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.
Time Frame: every month for 12 months
PROM will be assessed
every month for 12 months
Difference in patients satisfaction score at month 12 between groups.
Time Frame: every month for 12 months
patients satisfaction will be assessed
every month for 12 months
Cumulative IHS4 over month 7 to 12, correlated to hair loss after six months.
Time Frame: every month for 12 months
the amount of hair loss will be assessed and correlated to the cumulative IHS4
every month for 12 months
Cumulative IHS4 calculated over a time period of 3, 9 and 12 months between groups.
Time Frame: every month for 12 months
The cumulative IHS4 will be assessed after 3, 9 and 12 months
every month for 12 months
Difference in pustule and papule count during visits over month 1 to 12 between groups.
Time Frame: every month for 12 months
the number of papules and pustules will be assessed
every month for 12 months
Difference in (cumulative) abscess en nodule count over month 1 to 12 between groups.
Time Frame: every month for 12 months
number of abscesses and nodules will be assessed
every month for 12 months
Difference in number of times escape medication has been used over month 1 to 12 between groups.
Time Frame: every month for 12months
Number of escape medication will be assessed
every month for 12months
Difference of average duration of a flare, reported by the patient, over month 1 to 12 between groups.
Time Frame: every month for 12 months
Duration of a flare will be assessed
every month for 12 months
The difference in IHS4 and HS-PGA, measured every visit.
Time Frame: every month for 12 months
The IHS4 and HS-PGA will be assessed
every month for 12 months
Amount of clindamycin lotion use for both groups.
Time Frame: every month for 12 months
clindamycin 1% lotion will be weighted every visit
every month for 12 months
Difference in number of adverse events between groups.
Time Frame: every month for 12 months
safety will be assessed using adverse events
every month for 12 months
Incidence and severity of all adverse events (according to medDRA) will be analysed throughout the study.
Time Frame: every month for 12 months
safety will be assessed using adverse events
every month for 12 months
Histopathological: diameter hair shaft in axillary skin before and after treatment.
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
Biopsies will be taken for histopathological research
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
Histopathological: plugging of the hair follicle in the skin before and after treatment
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
Biopsies will be taken for histopathological research
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
Histopathological: immunohistochemistry in the skin before and after treatment
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
Biopsies will be taken for histopathological research
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
Histopathological: AMP expression in the skin before and after treatment
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
Biopsies will be taken for histopathological research
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erasmus Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hessel van der Zee, MD, PhD, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EMCD_22026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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