Trial Outcomes & Findings for Duobrii Treatment of Acne Keloidalis Nuchae (AKN) (NCT NCT05608499)

NCT ID: NCT05608499

Last Updated: 2025-11-04

Results Overview

Change in Lesion Count between baseline and Week 12

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 15 participants
• Primary outcome timeframe: Baseline and Week 12
• Results posted on: 2025-11-04

Participant Flow

Participant milestones

Measure	Duobrii Duobrii is the study treatment drug. Bryhali will only be used as a rescue treatment - in case of irritation with Duobrii. Duobrii: topical contains active drug lotion, once daily for 4 weeks then twice daily for 8 weeks Bryhali: 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.	Placebo Placebo Placebo: Topical does not contain active properties of study drug
Overall Study STARTED	10	5
Overall Study COMPLETED	9	4
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Duobrii Duobrii is the study treatment drug. Bryhali will only be used as a rescue treatment - in case of irritation with Duobrii. Duobrii: topical contains active drug lotion, once daily for 4 weeks then twice daily for 8 weeks Bryhali: 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.	Placebo Placebo Placebo: Topical does not contain active properties of study drug
Overall Study Lack of Efficacy	1	0
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Duobrii Treatment of Acne Keloidalis Nuchae (AKN)

Baseline characteristics by cohort

Measure	Duobrii n=10 Participants Duobrii is the study treatment drug. Bryhali will only be used as a rescue treatment - in case of irritation with Duobrii. Duobrii: topical contains active drug lotion, once daily for 4 weeks then twice daily for 8 weeks Bryhali: 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.	Placebo n=5 Participants Placebo Placebo: Topical does not contain active properties of study drug	Total n=15 Participants Total of all reporting groups
Age, Continuous	33 years STANDARD_DEVIATION 10.23 • n=15 Participants	32 years STANDARD_DEVIATION 6.67 • n=161 Participants	33 years STANDARD_DEVIATION 8.95 • n=100 Participants
Sex: Female, Male Female	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants
Sex: Female, Male Male	10 Participants n=15 Participants	5 Participants n=161 Participants	15 Participants n=100 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=15 Participants	0 Participants n=161 Participants	2 Participants n=100 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=15 Participants	5 Participants n=161 Participants	13 Participants n=100 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants
Race (NIH/OMB) Asian	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants
Race (NIH/OMB) Black or African American	8 Participants n=15 Participants	4 Participants n=161 Participants	12 Participants n=100 Participants
Race (NIH/OMB) White	2 Participants n=15 Participants	1 Participants n=161 Participants	3 Participants n=100 Participants
Race (NIH/OMB) More than one race	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Change in Lesion Count between baseline and Week 12

Outcome measures

Measure	Duobrii n=10 Participants Duobrii is the study treatment drug. Bryhali will only be used as a rescue treatment - in case of irritation with Duobrii. Duobrii: topical contains active drug lotion, once daily for 4 weeks then twice daily for 8 weeks Bryhali: 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.	Placebo n=5 Participants Placebo Placebo: Topical does not contain active properties of study drug
Change in Lesion Count	3.89 lesion count Standard Deviation 15.28	-5.5 lesion count Standard Deviation 15.78

SECONDARY outcome

Timeframe: Baseline and Week 12

Changes in Pain Rating Scale as compared to baseline. Full scale is 0-10, where higher scores indicate greater severity of AKN pain symptoms.

Outcome measures

Measure	Duobrii n=10 Participants Duobrii is the study treatment drug. Bryhali will only be used as a rescue treatment - in case of irritation with Duobrii. Duobrii: topical contains active drug lotion, once daily for 4 weeks then twice daily for 8 weeks Bryhali: 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.	Placebo n=5 Participants Placebo Placebo: Topical does not contain active properties of study drug
Changes in Pain Rating Scale	1 score on a scale Standard Deviation 2.45	-0.25 score on a scale Standard Deviation 0.957

SECONDARY outcome

Timeframe: Baseline and Week 12

Changes in Itch Rating Scale as compared to baseline. Full scale is 0-10, where higher scores indicate greater severity of AKN itch symptoms.

Outcome measures

Measure	Duobrii n=10 Participants Duobrii is the study treatment drug. Bryhali will only be used as a rescue treatment - in case of irritation with Duobrii. Duobrii: topical contains active drug lotion, once daily for 4 weeks then twice daily for 8 weeks Bryhali: 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.	Placebo n=5 Participants Placebo Placebo: Topical does not contain active properties of study drug
Changes in Itch Rating Scale	0.333 score on a scale Standard Deviation 2.12	-3 score on a scale Standard Deviation 1.83

Adverse Events

Duobrii

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Duobrii n=10 participants at risk Duobrii is the study treatment drug. Bryhali will only be used as a rescue treatment - in case of irritation with Duobrii. Duobrii: topical contains active drug lotion, once daily for 4 weeks then twice daily for 8 weeks Bryhali: 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.	Placebo n=5 participants at risk Placebo Placebo: Topical does not contain active properties of study drug
Skin and subcutaneous tissue disorders Scalp Irritation	20.0% 2/10 • 12 weeks	0.00% 0/5 • 12 weeks
Skin and subcutaneous tissue disorders Scalp Irritation /Erythema at site of AKN	10.0% 1/10 • 12 weeks	0.00% 0/5 • 12 weeks
Skin and subcutaneous tissue disorders Hypopigmentation	10.0% 1/10 • 12 weeks	0.00% 0/5 • 12 weeks
Skin and subcutaneous tissue disorders Hyperpigmentation	10.0% 1/10 • 12 weeks	0.00% 0/5 • 12 weeks

Additional Information

Giselle Singer

Icahn School of Medicine at Mount Sinai

Phone: 212-241-3288

Email: giselle.singer@mssm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place