Hidradenitis Suppurativa, Acne InversaHaLaNCT05762484
Efficacy of Laser Hair Removal Therapy in HS
A study testing Nd:YAG laser hair removal and Clindamycin 1 % Topical Lotion in people with Hidradenitis Suppurativa, Acne Inversa, run by Erasmus Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa, Acne Inversa
- What is being tested?
- Nd:YAG laser hair removal and Clindamycin 1 % Topical Lotion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IHS4 mild to moderate, without tunnels in the axillae.
- HS activity in at least one axilla.
- Age 18 years and over.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Hidradenitis Suppurativa, Acne Inversa
- Being tested
- Nd:YAG laser hair removal, Clindamycin 1 % Topical Lotion
- Keywords
- laser hair removal therapy
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nd:YAG laser hair removalProcedure or surgery
Using the Nd:YAG laser (cynergy), hair of the axillae will be removed.
Clindamycin 1 % Topical LotionDrug
Clindamycin 1% lotion if needed
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Clindamycin 1 % Topical Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in IHS4 over time, measured between month 7 to month 12
The IHS4 will be assessed monthly.
Measured: between month 7 to 12
Secondary outcomes (21)
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
Measured: 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.
NRS pain will be assessed
Measured: every month for 12 months
Change in skin related itch of the axillae, on a NRS, between baseline and month 12, and between groups.
NRS itch will be assessed
Measured: 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
Number of self reported flares will be assessed
Measured: 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.
PROM will be assessed
Measured: 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.
PROM will be assessed
Measured: every month for 12 months
Difference in patients satisfaction score at month 12 between groups.
patients satisfaction will be assessed
Measured: every month for 12 months
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
Measured: every month for 12 months
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
Measured: every month for 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
Measured: every month for 12 months
Difference in (cumulative) abscess en nodule count over month 1 to 12 between groups.
number of abscesses and nodules will be assessed
Measured: every month for 12 months
Difference in number of times escape medication has been used over month 1 to 12 between groups.
Number of escape medication will be assessed
Measured: every month for 12months
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
Measured: every month for 12 months
The difference in IHS4 and HS-PGA, measured every visit.
The IHS4 and HS-PGA will be assessed
Measured: every month for 12 months
Amount of clindamycin lotion use for both groups.
clindamycin 1% lotion will be weighted every visit
Measured: every month for 12 months
Difference in number of adverse events between groups.
safety will be assessed using adverse events
Measured: every month for 12 months
Incidence and severity of all adverse events (according to medDRA) will be analysed throughout the study.
safety will be assessed using adverse events
Measured: every month for 12 months
Histopathological: diameter hair shaft in axillary skin before and after treatment.
Biopsies will be taken for histopathological research
Measured: 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
Biopsies will be taken for histopathological research
Measured: 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
Biopsies will be taken for histopathological research
Measured: 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
Biopsies will be taken for histopathological research
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study startApr 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis Suppurativa, Acne InversaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT with intervention and control group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hessel H van der Zee, MD, PhD, Erasmus Medical Center
- Investigators
- Hessel van der Zee, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762484
- Sponsor's protocol ID
- EMCD_22026
- Acronym
- HaLa
- Status last verified
- Feb 2023
- First submitted
- 23 Dec 2022
- Last updated
- 9 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Laser Hair Removal Therapy in Patients With Mild to Moderate HS, a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05762484
- Acronym / sponsor ID
- HaLa / EMCD_22026
- Conditions
- Hidradenitis Suppurativa, Acne Inversa
- Keywords
- laser hair removal therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT with intervention and control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group, laser hair removal therapy | Experimental | Procedure: Nd:YAG laser hair removalPatients 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. |
| Control group, clindamycin 1% lotion if needed, standard care | Active comparator | Drug: Clindamycin 1 % Topical LotionPatients will use clindamycin 1% lotion of needed for 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- IHS4 mild to moderate, without tunnels in the axillae.
- HS activity in at least one axilla.
- Age 18 years and over.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nd:YAG laser hair removalUsing the Nd:YAG laser (cynergy), hair of the axillae will be removed. | Procedure or surgery | Intervention group, laser hair removal therapy |
| Clindamycin 1 % Topical LotionClindamycin 1% lotion if needed | Drug | Control group, clindamycin 1% lotion if needed, standard care |
Primary outcome
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.
21 secondary outcomes
Cumulative IHS4 over month 7 to month 12 between the two groups
Time frame: 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
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
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
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
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
Difference in patients satisfaction score at month 12 between groups.
Time frame: 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
Cumulative IHS4 calculated over a time period of 3, 9 and 12 months between groups.
Time frame: 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
Difference in (cumulative) abscess en nodule count over month 1 to 12 between groups.
Time frame: 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
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
The difference in IHS4 and HS-PGA, measured every visit.
Time frame: every month for 12 months
Amount of clindamycin lotion use for both groups.
Time frame: every month for 12 months
Difference in number of adverse events between groups.
Time frame: 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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hessel van der Zee, MD, PhD principal investigator
Erasmus Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Nd:YAG laser hair removal and Clindamycin 1 % Topical Lotion in people with Hidradenitis Suppurativa, Acne Inversa, run by Erasmus Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hessel van der Zee, MD, PhD (+31 10 704 0110, h.vanderzee@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in IHS4 over time, measured between month 7 to month 12 (time frame: between month 7 to 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.