search
Back to results

Duobrii Treatment of Acne Keloidalis Nuchae (AKN)

Primary Purpose

Acne Keloidalis Nuchae, AKN

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Duobrii
Placebo
Bryhali
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Keloidalis Nuchae

Eligibility Criteria

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

Inclusion Criteria: Male or female subject at least 18 years of age Subject is able to provide written informed consent and comply with the requirements of this study protocol Subjects have AKN class I or II (less than 6.5 cm in width) Subjects who are women of childbearing potential (WOCBP) must have a negative urine pregnancy test at screening and must be practicing an adequate and medically acceptable method of birth control for at least 30 days prior to Day 0 and at least 6 months after the last dose of study. Acceptable methods of birth control include: intrauterine device (IUD) oral; transdermal; implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study); tubal ligation; abstinence; barrier methods with spermicide. If not of child-bearing potential, subjects must have: a sterile or vasectomized partner; have had a hysterectomy; a bilateral oophorectomy or be clinically diagnosed infertile; or be in a menopausal state for at least a year. Subject is judged to be in good general health as determined by the principal investigator. Exclusion Criteria: unable to understand and provide written consent Have received prior intralesional steroids for AKN within the past 6 months Are using topical steroids or topical medications on their scalp within 4 weeks Have used Duobrii on the scalp for AKN or other scalp disorders Subject is pregnant or breastfeeding Use of prior systemic medication for AKN or acne (doxycycline or isotretinoin) or hair loss in the last 6 months Currently using topical minoxidil or prior use within the past 3 months Have a history of other or other active scalp/hair disease or other forms of or other forms of alopecia Are on systemic steroids or other immunosuppressants Have a history of auto-immune disease, thyroid disorder, or hypersensitivity to steroids.

Sites / Locations

  • Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Duobrii

Placebo

Arm Description

Duobrii is the study treatment drug. Bryhali will only be used as a rescue treatment - in case of irritation with Duobrii.

Placebo

Outcomes

Primary Outcome Measures

Changes in lesion count classification
Changes in lesion count classification as captured by photography. AKN Classification: Lesion Distribution Class I: sagittal width ≤ 3cm Class II: sagittal width < 3cm ≤ 6.5cm

Secondary Outcome Measures

Changes in Pain Rating Scale
Changes in Pain Rating Scale as compared to baseline. Full scale is 0-10, where higher scores indicate greater severity of AKN pain symptoms.
Changes in Itch Rating Scale
Changes in Itch Rating Scale as compared to baseline. Full scale is 0-10, where higher scores indicate greater severity of AKN itch symptoms.
Changes in degree of dyspigmentation
Changes in percent of treatment area affected with dyspigmentation as compared to baseline.

Full Information

First Posted
November 1, 2022
Last Updated
October 6, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Bausch Health Americas, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05608499
Brief Title
Duobrii Treatment of Acne Keloidalis Nuchae (AKN)
Official Title
Efficacy and Safety of Duobrii in the Management of Acne Keloidalis Nuchae (AKN)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Bausch Health Americas, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Acne keloidalis nuchae (AKN) is one of the chronic forms of scarring folliculitis, affecting predominantly the occipital scalp, seen mostly in men of African descent. Duobrii has the advantage of being the only high potency topical steroid-retinoid combination approved by the FDA with dermatologic indication. Researchers are proposing the off-labeled use of Duobrii for the management of early-mild AKN. The research team hypothesizes that subjects will experience significant clinical improvement in lesion counts. Patients will be followed with visits scheduled at baseline, 4 weeks, 8 weeks, and 12 weeks. During these in-clinic visits, there will be surveys regarding the severity of AKN symptoms, photographs, and clinical assessments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Keloidalis Nuchae, AKN

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Duobrii
Arm Type
Experimental
Arm Description
Duobrii is the study treatment drug. Bryhali will only be used as a rescue treatment - in case of irritation with Duobrii.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Duobrii
Other Intervention Name(s)
halobetasol propionate and tazarotene
Intervention Description
topical contains active drug lotion, once daily for 4 weeks then twice daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Topical does not contain active properties of study drug
Intervention Type
Drug
Intervention Name(s)
Bryhali
Other Intervention Name(s)
halobetasol propionate
Intervention Description
Bryhali will only be used as a rescue treatment - in case of irritation with Duobrii. Bryhali lotion once daily up to 12 weeks only if Duobrii is not tolerated.
Primary Outcome Measure Information:
Title
Changes in lesion count classification
Description
Changes in lesion count classification as captured by photography. AKN Classification: Lesion Distribution Class I: sagittal width ≤ 3cm Class II: sagittal width < 3cm ≤ 6.5cm
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Changes in Pain Rating Scale
Description
Changes in Pain Rating Scale as compared to baseline. Full scale is 0-10, where higher scores indicate greater severity of AKN pain symptoms.
Time Frame
Baseline and Week 12
Title
Changes in Itch Rating Scale
Description
Changes in Itch Rating Scale as compared to baseline. Full scale is 0-10, where higher scores indicate greater severity of AKN itch symptoms.
Time Frame
Baseline and Week 12
Title
Changes in degree of dyspigmentation
Description
Changes in percent of treatment area affected with dyspigmentation as compared to baseline.
Time Frame
Baseline and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subject at least 18 years of age Subject is able to provide written informed consent and comply with the requirements of this study protocol Subjects have AKN class I or II (less than 6.5 cm in width) Subjects who are women of childbearing potential (WOCBP) must have a negative urine pregnancy test at screening and must be practicing an adequate and medically acceptable method of birth control for at least 30 days prior to Day 0 and at least 6 months after the last dose of study. Acceptable methods of birth control include: intrauterine device (IUD) oral; transdermal; implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study); tubal ligation; abstinence; barrier methods with spermicide. If not of child-bearing potential, subjects must have: a sterile or vasectomized partner; have had a hysterectomy; a bilateral oophorectomy or be clinically diagnosed infertile; or be in a menopausal state for at least a year. Subject is judged to be in good general health as determined by the principal investigator. Exclusion Criteria: unable to understand and provide written consent Have received prior intralesional steroids for AKN within the past 6 months Are using topical steroids or topical medications on their scalp within 4 weeks Have used Duobrii on the scalp for AKN or other scalp disorders Subject is pregnant or breastfeeding Use of prior systemic medication for AKN or acne (doxycycline or isotretinoin) or hair loss in the last 6 months Currently using topical minoxidil or prior use within the past 3 months Have a history of other or other active scalp/hair disease or other forms of or other forms of alopecia Are on systemic steroids or other immunosuppressants Have a history of auto-immune disease, thyroid disorder, or hypersensitivity to steroids.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giselle Singer
Phone
212-241-3288
Email
giselle.singer@mssm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Savina Sikand
Phone
212-241-3288
Email
savina.sikand@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Guttman, M.D.
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giselle Singer
Phone
212-241-3288
Email
giselle.singer@mssm.edu
First Name & Middle Initial & Last Name & Degree
Emma Guttman

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available. Aggregated data will be discussed in the final published article.

Learn more about this trial

Duobrii Treatment of Acne Keloidalis Nuchae (AKN)

We'll reach out to this number within 24 hrs