Hidradenitis SuppurativaPhase 4NCT04582669

Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa

A Phase 4 study testing Intralesional Triamcinolone 10 mg/mL, Intralesional Triamcinolone 20 mg/mL and Intralesional Triamcinolone 40 mg/mL in people with Hidradenitis Suppurativa, run by Montefiore Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 13 years and olderHealthy volunteers can take part
Conditions the study is for: Hidradenitis Suppurativa
What is being tested?: Intralesional Triamcinolone 10 mg/mL, Intralesional Triamcinolone 20 mg/mL and Intralesional Triamcinolone 40 mg/mL
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 11 participants
Where: 1 siteUnited States
Study dates: 24 Jan 2022to 12 Oct 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 13 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Age > 13 years old.
Subject must voluntarily sign and date an informed consent, approved by an independent ethics committee / institutional review board.
Subject is willing to comply with the procedures in this protocol.
The subject must be diagnosed with HS and receiving care at HSC
Subjects with Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score between 2 and 5
The subject must have an inflamed nodule or abscess at the time of enrollment.

Who cannot join

The subject has an HS-PGA score of 0 or 1
The subject has received ILTAC less than 8 days prior to the initial visit.
The subject does not have capacity to consent to the study.
The subject is has taken systemic steroids at least 4 weeks prior to the time of enrollment.
The subject has a known allergy or history of adverse reaction to steroids.
The subject is pregnant.
Subjects who have received a biologic therapy two weeks before and during the study period.

Trial locations and contacts

1 site in 1 country.

United States1 site

Steven Cohen
The Bronx, New York, 10467

Other trials in United States

About this study

Currently, there is limited evidence showing increased resolution of HS flares with higher doses of intralesional triamcinolone (ILTAC) as well as a difference in side effect profile between the doses. The goal of this study is to determine the efficacy of treating HS flares with ILTAC-10, ILTAC-20 and ILTAC-40 and to investigate the side effect profile for each dose.

Read the detailed description

A double-blinded, randomized, placebo-controlled study examining the relative efficacy of ILTAC-10, ILTAC-20, and ILTAC-40 versus placebo for acute flares of HS in subjects with moderate to severe HS. The duration of the study will be approximately 4 weeks for each enrolled patient and will include an initial screening/randomization/treatment visit and a 4-week follow-up period. During the initial visit, subjects who meet the study's eligibility criteria will be randomized to receive either ILTAC-10, ILTAC-20, ILTAC-40, or placebo in a 1:1:1:1 ratio. Study subjects will then receive treatment or placebo. The follow-up period will be of 4 weeks and will consist of 3 phone calls and 1 live visit, including an end of study visit on week 4 after randomization.

Conditions: Hidradenitis Suppurativa
Being tested: Intralesional Triamcinolone 10 mg/mL, Intralesional Triamcinolone 20 mg/mL, Intralesional Triamcinolone 40 mg/mL, Placebo
Medical subject headings: Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intralesional Triamcinolone 10 mg/mLDrug
Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
Intralesional Triamcinolone 20 mg/mLDrug
Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
Intralesional Triamcinolone 40 mg/mLDrug
Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.
PlaceboDrug
Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.

Study groups in NCT04582669
Study group	Role	What they receive
Sodium Chloride 0.9%	Placebo comparator	Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL. Receives: Drug: Placebo
Intralesional Triamcinolone 10 mg/mL	Active comparator	Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL. Receives: Drug: Intralesional Triamcinolone 10 mg/mL
Intralesional Triamcinolone 20 mg/mL	Experimental	Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL. Receives: Drug: Intralesional Triamcinolone 20 mg/mL
Intralesional Triamcinolone 40 mg/mL	Experimental	Each active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL. Receives: Drug: Intralesional Triamcinolone 40 mg/mL

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Numeric Rating Scale (NRS)
Numeric Rating Scale is a pain scale scored with whole integers from 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable". Higher score indicates worse pain.
Measured: Baseline, Days 2, 6, 14, and 28

Secondary outcomes (13)

Change From Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HS-PGA) Score
HS-PGA is a six-staged physician global assessment tool (score ranges from 0 to 5) based on number of HS lesions including inflammatory and/or non-inflammatory nodules, abscesses, and draining fistulas. Higher HS-PGA score indicates more severe HS disease.
Measured: Baseline and Week 4
Change From Baseline in C-reactive Protein (CRP)
CRP (measured in mg/dL) is an inflammatory marker. A higher value is correlated with more severe disease.
Measured: Baseline and Week 4
Change From Baseline in Hidradenitis Suppurativa (HS) Lesion Size
HS lesion size will be measured using a metric ruler in centimeters. Measurement will be standardized according to greatest diameter as lesions will be measured from edge of one border to the edge of the opposite border.
Measured: Baseline and Week 4
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)
Patient-Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered outcome measures that assesses physical, mental, and psychosocial health in adults and children. Clinical measures of health outcome includes physical function, mobility, pain, fatigue, emotional stress, ability to participate in social roles, sleep-related impairment, depressive symptoms/sadness, anxiety/fear, and anger. The scores are rated on a scale from 0 to 100 with "0" being "best functioning" and "100" being "worst functioning".
Measured: Baseline, Days 2, 6, 14, and 28
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
Evaluate the morphologic changes in participant's skin from baseline, specifically assessing
1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.
3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
Measured: Baseline
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
Evaluate the morphologic changes in participant's skin from baseline, specifically assessing
1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.
3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
Measured: Day 2
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
Evaluate the morphologic changes in participant's skin from baseline, specifically assessing
1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.
3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
Measured: Day 6
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
Evaluate the morphologic changes in participant's skin from baseline, specifically assessing
1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.
3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
Measured: Day 14
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
Evaluate the morphologic changes in participant's skin from baseline, specifically assessing
1. Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
2. Capillary dilation(s) are bright red lines on skin surface and appear as linear or wavy or serpiginous; classified as telangiectasia(s) and/or spider angiomas.
3. Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.
Measured: Day 28
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
ESR (measured in mm/h), is a pro-inflammatory marker. Higher ESR levels are correlated with greater hidradenitis suppurativa disease activity and worse clinical outcome.
Measured: Baseline and Week 4
Baseline Patient Satisfaction Likert Scale
Likert scale is a rating system that is designed to measure participant's overall attitude and perception regarding one's health and hidradenitis suppurativa. The scores range from 1 to 5 with "1" being "very unsatisfied" to "5" being "very satisfied". Higher scores indicate higher satisfaction.
Measured: Baseline
Change From Baseline in Patient Satisfaction Likert Scale
Likert scale is a rating system that is designed to measure participant's overall attitude and perception regarding one's health and hidradenitis suppurativa. The scores range from 1 to 5 with "1" being "very unsatisfied" to "5" being "very satisfied". Higher scores indicate higher satisfaction.
Measured: Days 2, 6, 14, and 28
Change From Baseline in Interleukin-6 (IL-6)
IL-6 (measured in pg/mL), is a pro-inflammatory cytokine. Higher IL-6 levels are correlated with greater hidradenitis suppurativa disease activity and worse clinical outcome.
Measured: Baseline and Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jan 202212 Oct 2022

First posted9 Oct 2020
Study start24 Jan 2022
Primary completion12 Oct 2022
Study completion12 Oct 2022

Why it stopped: This study was administratively closed.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
More trials run by Montefiore 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04582669
Sponsor's protocol ID: 2020-12227
Status last verified: Oct 2023
First submitted: 29 Sep 2020
Last updated: 13 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis

All Hidradenitis Suppurativa trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing Intralesional Triamcinolone Dosing for Hidradenitis Suppurativa
ClinicalTrials.gov ID: NCT04582669
Acronym / sponsor ID: 2020-12227
Conditions: Hidradenitis Suppurativa
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: This study was administratively closed.
Enrolment: 11 participants (actual)
Lead sponsor: Montefiore Medical CenterUniversity, hospital or other
Study start: 24 Jan 2022 (actual)
Primary completion: 12 Oct 2022 (actual)
Study completion: 12 Oct 2022 (actual)
First posted: 9 Oct 2020 (actual)
Results: Posted 13 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Sodium Chloride 0.9%	Placebo comparator	Drug: PlaceboEach active hidradenitis suppurativa lesion will be injected with up to 1 mL of sodium chloride 0.9% in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 10 mg/mL	Active comparator	Drug: Intralesional Triamcinolone 10 mg/mLEach active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 20 mg/mL	Experimental	Drug: Intralesional Triamcinolone 20 mg/mLEach active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.
Intralesional Triamcinolone 40 mg/mL	Experimental	Drug: Intralesional Triamcinolone 40 mg/mLEach active hidradenitis suppurativa lesion will be injected with up to 1 mL of intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas. The maximum treatment volume is 3 mL.

Who may qualify

Ages: 13 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Age > 13 years old.
Subject must voluntarily sign and date an informed consent, approved by an independent ethics committee / institutional review board.
Subject is willing to comply with the procedures in this protocol.
The subject must be diagnosed with HS and receiving care at HSC
Subjects with Hidradenitis Suppurativa Physician Global Assessment (HS-PGA) score between 2 and 5

Key exclusion criteria (7 listed)

The subject has an HS-PGA score of 0 or 1
The subject has received ILTAC less than 8 days prior to the initial visit.
The subject does not have capacity to consent to the study.
The subject is has taken systemic steroids at least 4 weeks prior to the time of enrollment.
The subject has a known allergy or history of adverse reaction to steroids.

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
Intralesional Triamcinolone 10 mg/mLInjection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.	Drug	Intralesional Triamcinolone 10 mg/mL
Intralesional Triamcinolone 20 mg/mLInjection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.	Drug	Intralesional Triamcinolone 20 mg/mL
Intralesional Triamcinolone 40 mg/mLInjection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.	Drug	Intralesional Triamcinolone 40 mg/mL
PlaceboInjection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.	Drug	Sodium Chloride 0.9%

Primary outcome

Change From Baseline in Numeric Rating Scale (NRS)
Time frame: Baseline, Days 2, 6, 14, and 28
Numeric Rating Scale is a pain scale scored with whole integers from 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable". Higher score indicates worse pain.

13 secondary outcomes

Change From Baseline in Hidradenitis Suppurativa-Physician Global Assessment (HS-PGA) Score
Time frame: Baseline and Week 4
Change From Baseline in C-reactive Protein (CRP)
Time frame: Baseline and Week 4
Change From Baseline in Hidradenitis Suppurativa (HS) Lesion Size
Time frame: Baseline and Week 4
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: Baseline, Days 2, 6, 14, and 28
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
Time frame: Baseline
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
Time frame: Day 2
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
Time frame: Day 6
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
Time frame: Day 14
Percentage of Subjects Reporting Thinning and/or Atrophy of the Skin, Acneiform Lesion(s), Capillary Dilation(s), and Dyschromia When Compared to Baseline.
Time frame: Day 28
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline and Week 4
Baseline Patient Satisfaction Likert Scale
Time frame: Baseline
Change From Baseline in Patient Satisfaction Likert Scale
Time frame: Days 2, 6, 14, and 28
Change From Baseline in Interleukin-6 (IL-6)
Time frame: Baseline and Week 4

Results and safety

Results posted to the registry on 13 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sodium Chloride 0.9%	3	2
Intralesional Triamcinolone 10 mg/mL	3	2
Intralesional Triamcinolone 20 mg/mL	2	0
Intralesional Triamcinolone 40 mg/mL	3	1

Primary outcome: Change From Baseline in Numeric Rating Scale (NRS)

Time frame: Baseline, Days 2, 6, 14, and 28

Population analysed: NRS scoring data was not collected and aggregated and/or analyzed at any of the identified timepoints.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sodium Chloride 0.9%	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Intralesional Triamcinolone 10 mg/mL	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Intralesional Triamcinolone 20 mg/mL	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Intralesional Triamcinolone 40 mg/mL	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hidradenitis Suppurativa

Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis

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.

Steven R Cohen, MD, MPH principal investigator

Albert Einstein College of Medicine Montefiore Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Numeric Rating Scale (NRS) (time frame: Baseline, Days 2, 6, 14, and 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04582669.

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 13 Nov 2023.