Trial Outcomes & Findings for Study the Safety and Efficacy of DBI-001 Gel Versus Aqueous Gel (NCT NCT05253755)
NCT ID: NCT05253755
Last Updated: 2023-11-08
Results Overview
Change from baseline in individual signs and symptoms of Atopic Dermatitis (components of the ADSI score) at days 7, 14, 21, 28, 35, and 42 of sites treated with DBI-001 Gel or Aqueous Gel Atopic Dermatitis Severity Index: The ADSI score represents the sum of the individual severity scores of none, mild, moderate, or severe for the following component signs and symptoms: erythema, pruritus, exudation, excoriation, and lichenification. To calculate the ADSI score, the component scores are added together. Scale for the individual components: 0=none 1. mild 2. moderate 3. severe
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
42 days of participation
Results posted on
2023-11-08
Participant Flow
Unit of analysis: bilateral target lesions
Participant milestones
| Measure |
DBI-001 Gel and Aqueous Gel
DBI-001: Topical application of DBI-001 gel on skin affected with atopic dermatitis.
Aqueous Gel: Topical application of aqueous gel on skin affected with atopic dermatitis.
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|---|---|
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Overall Study
STARTED
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10 20
|
|
Overall Study
COMPLETED
|
9 18
|
|
Overall Study
NOT COMPLETED
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1 2
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study the Safety and Efficacy of DBI-001 Gel Versus Aqueous Gel
Baseline characteristics by cohort
| Measure |
DBI-001 and Aqueous Gel
n=10 Participants
DBI-001: Topical application of DBI-001 gel on skin affected with atopic dermatitis.
Aqueous gel: Topical application of aqueous gel on skin affected with atopic dermatitis.
(This study is a within-subject bilateral controlled study)
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|---|---|
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Age, Continuous
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30.8 years
STANDARD_DEVIATION 14.57 • n=99 Participants
|
|
Sex: Female, Male
Female
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6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 42 days of participationPopulation: This study is a within-subject bilateral controlled study.
Change from baseline in individual signs and symptoms of Atopic Dermatitis (components of the ADSI score) at days 7, 14, 21, 28, 35, and 42 of sites treated with DBI-001 Gel or Aqueous Gel Atopic Dermatitis Severity Index: The ADSI score represents the sum of the individual severity scores of none, mild, moderate, or severe for the following component signs and symptoms: erythema, pruritus, exudation, excoriation, and lichenification. To calculate the ADSI score, the component scores are added together. Scale for the individual components: 0=none 1. mild 2. moderate 3. severe
Outcome measures
| Measure |
DBI-001 Gel
n=8 Participants
Topical application of DBI-001 gel on skin affected with atopic dermatitis.
|
Aqueous Gel
n=8 Participants
Topical application of aqueous gel on skin affected with atopic dermatitis.
|
|---|---|---|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Lichenification Day 0
|
2 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.75 to 2.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Pruritus Day 14
|
1 score on a scale
Interval 1.0 to 1.25
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Erythema Day 0
|
2 score on a scale
Interval 2.0 to 2.0
|
2 score on a scale
Interval 2.0 to 2.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Erythema Day 7
|
2 score on a scale
Interval 2.0 to 2.0
|
2 score on a scale
Interval 1.75 to 2.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Erythema Day 14
|
2 score on a scale
Interval 1.0 to 2.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Erythema Day 21
|
2 score on a scale
Interval 1.0 to 2.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Erythema Day 28
|
1 score on a scale
Interval 1.0 to 1.25
|
1 score on a scale
Interval 0.75 to 1.25
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Erythema Day 35
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1 score on a scale
Interval 1.0 to 2.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Erythema Day 42
|
1.5 score on a scale
Interval 1.0 to 2.0
|
1 score on a scale
Interval 1.0 to 2.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Pruritus Day 0
|
2 score on a scale
Interval 1.75 to 2.0
|
2 score on a scale
Interval 1.0 to 2.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Pruritus Day 7
|
1.5 score on a scale
Interval 1.0 to 2.0
|
1.5 score on a scale
Interval 1.0 to 2.25
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Pruritus Day 21
|
1 score on a scale
Interval 0.0 to 1.0
|
1 score on a scale
Interval 0.75 to 2.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Pruritus Day 28
|
1 score on a scale
Interval 0.0 to 1.0
|
1 score on a scale
Interval 0.75 to 2.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Pruritus Day 35
|
1 score on a scale
Interval 0.75 to 1.25
|
1.5 score on a scale
Interval 0.75 to 2.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Pruritus Day 42
|
1 score on a scale
Interval 0.0 to 1.25
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1 score on a scale
Interval 0.0 to 2.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Exudation Day 0
|
0.5 score on a scale
Interval 0.0 to 1.0
|
0.5 score on a scale
Interval 0.0 to 1.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Exudation day 7
|
1 score on a scale
Interval 0.75 to 1.0
|
0.5 score on a scale
Interval 0.0 to 1.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Exudation day 14
|
0.5 score on a scale
Interval 0.0 to 1.0
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0 score on a scale
Interval 0.0 to 1.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Exudation day 21
|
0.5 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Exudation day 28
|
0.5 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Exudation day 35
|
0.5 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Exudation day 42
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Excoriation Day 0
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1 score on a scale
Interval 1.0 to 2.0
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1 score on a scale
Interval 1.0 to 2.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Excoriation Day 7
|
1 score on a scale
Interval 1.0 to 1.25
|
1 score on a scale
Interval 1.0 to 1.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Excoriation Day 14
|
1 score on a scale
Interval 0.0 to 1.25
|
1 score on a scale
Interval 0.0 to 1.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Excoriation Day 21
|
1 score on a scale
Interval 0.0 to 1.25
|
1 score on a scale
Interval 0.0 to 1.25
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Excoriation Day 28
|
1 score on a scale
Interval 0.0 to 2.0
|
0.5 score on a scale
Interval 0.0 to 1.25
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Excoriation Day 35
|
1 score on a scale
Interval 0.0 to 1.0
|
1 score on a scale
Interval 0.0 to 1.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Excoriation Day 42
|
1 score on a scale
Interval 0.75 to 1.0
|
1 score on a scale
Interval 0.0 to 1.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Lichenification Day 7
|
2 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.75 to 2.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Lichenification Day 14
|
2 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 2.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Lichenification Day 21
|
2 score on a scale
Interval 1.75 to 2.0
|
2 score on a scale
Interval 1.75 to 2.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Lichenification Day 28
|
2 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 2.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Lichenification Day 35
|
2 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 2.0
|
|
Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis
Lichenification Day 42
|
2 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 2.0
|
Adverse Events
DBI-001 Gel
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Aqueous Gel
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DBI-001 Gel
n=10 participants at risk
Topical application of DBI-001 gel on skin affected with atopic dermatitis.
|
Aqueous Gel
n=10 participants at risk
Topical application of Aqueous gel on skin affected with atopic dermatitis.
|
|---|---|---|
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Gastrointestinal disorders
Emesis
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0.00%
0/10 • Approximately 56 days. Timeframe details of the 4 adverse events: Pruritus started after Baseline visit and resolved before Day 7 Emesis started after Day 7 and resolved before Day 14 Erythematous papules started after Day 28 visit and resolved before Day 35 visit Gout Flare started on Day 14
|
10.0%
1/10 • Number of events 1 • Approximately 56 days. Timeframe details of the 4 adverse events: Pruritus started after Baseline visit and resolved before Day 7 Emesis started after Day 7 and resolved before Day 14 Erythematous papules started after Day 28 visit and resolved before Day 35 visit Gout Flare started on Day 14
|
|
Skin and subcutaneous tissue disorders
Allergic Reaction to cats (pruritus)
|
10.0%
1/10 • Number of events 1 • Approximately 56 days. Timeframe details of the 4 adverse events: Pruritus started after Baseline visit and resolved before Day 7 Emesis started after Day 7 and resolved before Day 14 Erythematous papules started after Day 28 visit and resolved before Day 35 visit Gout Flare started on Day 14
|
0.00%
0/10 • Approximately 56 days. Timeframe details of the 4 adverse events: Pruritus started after Baseline visit and resolved before Day 7 Emesis started after Day 7 and resolved before Day 14 Erythematous papules started after Day 28 visit and resolved before Day 35 visit Gout Flare started on Day 14
|
|
Skin and subcutaneous tissue disorders
Erythematous papules
|
10.0%
1/10 • Number of events 1 • Approximately 56 days. Timeframe details of the 4 adverse events: Pruritus started after Baseline visit and resolved before Day 7 Emesis started after Day 7 and resolved before Day 14 Erythematous papules started after Day 28 visit and resolved before Day 35 visit Gout Flare started on Day 14
|
0.00%
0/10 • Approximately 56 days. Timeframe details of the 4 adverse events: Pruritus started after Baseline visit and resolved before Day 7 Emesis started after Day 7 and resolved before Day 14 Erythematous papules started after Day 28 visit and resolved before Day 35 visit Gout Flare started on Day 14
|
|
Musculoskeletal and connective tissue disorders
Gout flare
|
0.00%
0/10 • Approximately 56 days. Timeframe details of the 4 adverse events: Pruritus started after Baseline visit and resolved before Day 7 Emesis started after Day 7 and resolved before Day 14 Erythematous papules started after Day 28 visit and resolved before Day 35 visit Gout Flare started on Day 14
|
10.0%
1/10 • Number of events 1 • Approximately 56 days. Timeframe details of the 4 adverse events: Pruritus started after Baseline visit and resolved before Day 7 Emesis started after Day 7 and resolved before Day 14 Erythematous papules started after Day 28 visit and resolved before Day 35 visit Gout Flare started on Day 14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER