Optimizing Intralesional Triamcinolone Dosing for Hidrade... | NCT04582669

Optimizing Intralesional Triamcinolone Dosing for Hidrade... | NCT04582669 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.	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.	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.	Drug: Intralesional Triamcinolone 40 mg/mL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intralesional Triamcinolone 10 mg/mL	Drug	Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.	Intralesional Triamcinolone 10 mg/mL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline, Days 2, 6, 14, and 28

Secondary Outcomes

Measure	Description	Time Frame
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.	Baseline and Week 4

Contacts/Locations Module

Name	Affiliation	Role
Steven R Cohen, MD, MPH	Albert Einstein College of Medicine Montefiore Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Steven Cohen		The Bronx	New York	10467	United States

Arm/Group Information

ID	Title	Description
FG000	Sodium Chloride 0.9%	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. Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
FG001	Intralesional Triamcinolone 10 mg/mL	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. Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
FG002	Intralesional Triamcinolone 20 mg/mL	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. Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
FG003	Intralesional Triamcinolone 40 mg/mL	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. Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0003 subjects FG0013 subjects FG0022 subjects FG0033 subjects
COMPLETED		FG0002 subjects FG0012 subjects FG0020 subjects FG0031 subjects
NOT COMPLETED		FG0001 subjects FG0011 subjects FG0022 subjects FG0032 subjects

Type	Comment	Reasons
Subject missed appointment(s).		FG0001 subjects FG0010 subjects FG0021 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Sodium Chloride 0.9%	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. Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
BG001	Intralesional Triamcinolone 10 mg/mL

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Customized			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

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

Posted

Baseline, Days 2, 6, 14, and 28

ID	Title	Description
OG000	Sodium Chloride 0.9%	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. Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
OG001	Intralesional Triamcinolone 10 mg/mL

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Sodium Chloride 0.9%	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. Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Haley Heibel, MD	Montefiore Medical Center	(718) 920-8352		hheibel@montefiore.org

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 12, 2021	Aug 29, 2023	Prot_SAP_000.pdf

Condition Browse Module

ID	Term
D017497	Hidradenitis Suppurativa

ID	Term
D017192	Skin Diseases, Bacterial
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Title

Denominators

Categories

Title	Measurements
Age 20-29 years old	BG0003 BG0012 BG0020 BG0032 BG0047
Age 30-39 years old	BG0000 BG0010 BG0020 BG0031 BG004
Age 40-49 years old	BG0000 BG0011 BG0021 BG0030 BG004
Age 50-59 years old	BG0000 BG0010 BG0020 BG0030 BG004
Age 60-69 years old	BG0000 BG0010 BG0021 BG0030 BG004

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

African American/Black

Title	Measurements
	BG0002 BG0010 BG0020 BG0031 BG0043

Caucasian

Title	Measurements
	BG0000 BG0010 BG0020 BG003

American Indian/Alaskan Native

Title	Measurements
	BG0000 BG0010 BG0020 BG003

Pacific Islander

Title	Measurements
	BG0000 BG0010 BG0020 BG003

Hispanic

Title	Measurements
	BG0000 BG0013 BG0022 BG003

Asian

Title	Measurements
	BG0000 BG0010 BG0020 BG003

Other

Title	Measurements
	BG0001 BG0010 BG0020 BG003

Secondary

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.

HS-PGA scoring data was not collected and aggregated and/or analyzed at any of the identified timepoints.

Posted

Baseline and Week 4

ID	Title	Description
OG000	Sodium Chloride 0.9%	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. Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
OG001	Intralesional Triamcinolone 10 mg/mL	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. Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
OG002	Intralesional Triamcinolone 20 mg/mL	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. Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
OG003	Intralesional Triamcinolone 40 mg/mL	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. Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

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.

CRP data was not collected and aggregated and/or analyzed at any of the identified timepoints. Laboratory analyses were not conducted.

Posted

Baseline and Week 4

ID	Title	Description
OG000	Sodium Chloride 0.9%	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. Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
OG001	Intralesional Triamcinolone 10 mg/mL	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. Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
OG002	Intralesional Triamcinolone 20 mg/mL	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. Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
OG003	Intralesional Triamcinolone 40 mg/mL	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. Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

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.

HS lesion size data was not collected and aggregated and/or analyzed at any of the identified timepoints.

Posted

Baseline and Week 4

ID	Title	Description
OG000	Sodium Chloride 0.9%	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. Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
OG001	Intralesional Triamcinolone 10 mg/mL	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. Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
OG002	Intralesional Triamcinolone 20 mg/mL	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. Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
OG003	Intralesional Triamcinolone 40 mg/mL	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. Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

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".

PROMIS data was not collected/aggregated and therefore not analyzed at any of the identified timepoints.

Posted

Baseline, Days 2, 6, 14, and 28

ID	Title	Description
OG000	Sodium Chloride 0.9%	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. Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
OG001	Intralesional Triamcinolone 10 mg/mL	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. Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
OG002	Intralesional Triamcinolone 20 mg/mL	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. Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
OG003	Intralesional Triamcinolone 40 mg/mL	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. Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

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

Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
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.
Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.

Posted

Count of Participants

Participants

Baseline

ID	Title	Description
OG000	Sodium Chloride 0.9%	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. Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
OG001	Intralesional Triamcinolone 10 mg/mL	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. Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
OG002	Intralesional Triamcinolone 20 mg/mL	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. Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
OG003	Intralesional Triamcinolone 40 mg/mL	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. Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.

Units	Counts
Participants	OG0003 OG0013 OG0022 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Secondary

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

Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
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.
Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.

There were two fewer subjects than baseline because subject(s) did not present for visit and/or meet eligibility criteria, and data was not collected and/or analyzed.

Posted

Count of Participants

Participants

Day 2

ID	Title	Description
OG000	Sodium Chloride 0.9%	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. Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
OG001	Intralesional Triamcinolone 10 mg/mL	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. Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
OG002	Intralesional Triamcinolone 20 mg/mL	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. Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
OG003	Intralesional Triamcinolone 40 mg/mL	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. Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.

Units	Counts
Participants	OG0003 OG0012 OG0021 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Secondary

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

Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
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.
Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.

There was one fewer subject than baseline because subject did not meet eligibility criteria, and data was not collected and/or analyzed.

Posted

Count of Participants

Participants

Day 6

ID	Title	Description
OG000	Sodium Chloride 0.9%	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. Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
OG001	Intralesional Triamcinolone 10 mg/mL	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. Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
OG002	Intralesional Triamcinolone 20 mg/mL	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. Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
OG003	Intralesional Triamcinolone 40 mg/mL	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. Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.

Units	Counts
Participants	OG0003 OG0012 OG0022 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Secondary

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

Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
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.
Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.

There were four fewer subjects than baseline because subject(s) did not present for visit and/or meet eligibility criteria, and data was not collected and/or analyzed.

Posted

Count of Participants

Participants

Day 14

ID	Title	Description
OG000	Sodium Chloride 0.9%	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. Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
OG001	Intralesional Triamcinolone 10 mg/mL	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. Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
OG002	Intralesional Triamcinolone 20 mg/mL	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. Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
OG003	Intralesional Triamcinolone 40 mg/mL	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. Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.

Units	Counts
Participants	OG0002 OG0012 OG0020 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Secondary

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

Acneiform lesion(s) are characterized by papules and pustules resembling acne vulgaris
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.
Dyschromia refers to alteration in skin pigmentation and can involve both hyperpigmented or hypopigmented macules.

There were six fewer subjects than baseline because subject(s) did not present for visit and/or meet eligibility criteria, and data was not collected and/or analyzed.

Posted

Count of Participants

Participants

Day 28

ID	Title	Description
OG000	Sodium Chloride 0.9%	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. Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
OG001	Intralesional Triamcinolone 10 mg/mL	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. Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
OG002	Intralesional Triamcinolone 20 mg/mL	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. Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
OG003	Intralesional Triamcinolone 40 mg/mL	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. Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.

Units	Counts
Participants	OG0002 OG0012 OG0020 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Secondary

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.

ESR data was not collected/aggregated and therefore not analyzed at any of the identified timepoints. Laboratory analyses were not conducted.

Posted

Baseline and Week 4

ID	Title	Description
OG000	Sodium Chloride 0.9%	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. Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
OG001	Intralesional Triamcinolone 10 mg/mL	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. Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
OG002	Intralesional Triamcinolone 20 mg/mL	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. Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
OG003	Intralesional Triamcinolone 40 mg/mL	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. Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

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.

Patient satisfaction data was not collected/aggregated and therefore not analyzed.

Posted

Baseline

ID	Title	Description
OG000	Sodium Chloride 0.9%	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. Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
OG001	Intralesional Triamcinolone 10 mg/mL	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. Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
OG002	Intralesional Triamcinolone 20 mg/mL	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. Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
OG003	Intralesional Triamcinolone 40 mg/mL	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. Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

Change From Baseline in Patient Satisfaction Likert Scale

Change from baseline data for patient satisfaction was not collected/aggregated and therefore not analyzed at any of the identified timepoints.

Posted

Days 2, 6, 14, and 28

ID	Title	Description
OG000	Sodium Chloride 0.9%	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. Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
OG001	Intralesional Triamcinolone 10 mg/mL	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. Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
OG002	Intralesional Triamcinolone 20 mg/mL	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. Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
OG003	Intralesional Triamcinolone 40 mg/mL	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. Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Secondary

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.

IL-6 data was not collected/aggregated and therefore not analyzed at any of the identified timepoints. Laboratory analyses were not conducted.

Posted

Baseline and Week 4

ID	Title	Description
OG000	Sodium Chloride 0.9%	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. Placebo: Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
OG001	Intralesional Triamcinolone 10 mg/mL	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. Intralesional Triamcinolone 10 mg/mL: Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
OG002	Intralesional Triamcinolone 20 mg/mL	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. Intralesional Triamcinolone 20 mg/mL: Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
OG003	Intralesional Triamcinolone 40 mg/mL	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. Intralesional Triamcinolone 40 mg/mL: Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003