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NCT05253755 · ClinicalTrials.gov registry record · Phase 2

Study the Safety and Efficacy of DBI-001 Gel Versus Aqueous Gel

A Phase 2 study, sponsored by DermBiont.

Terminated
Registry status
Phase 2
Development phase
10
Enrollment target

NCT05253755: Clinical Trial Phase 2 study, sponsored by DermBiont.

NCT05253755 is a Phase 2 study that was terminated before completion, run by DermBiont. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05253755, a Phase 2 study, was terminated before completion, sponsored by DermBiont.

TERMINATED
Registry status
Phase 2
Development phase
10 participants
Enrollment target

Study Summary

The purpose for this study is to assess the Safety and Efficacy of Daily Application for 4 weeks of DBI-001 Gel Versus Aqueous Gel in Subjects with Atopic Dermatitis

Primary Outcome

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 t

Interventions

  • BIOLOGICAL DBI-001
  • BIOLOGICAL Aqueous gel

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2021-10-06
Est. Completion 2022-09-09
Phase Phase 2
DermBiont

4 total trials

Why NCT05253755 stopped before completion

NCT05253755 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 2 interventions - of which DBI-001 is the first listed.

NCT05253755 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05253755 about?

NCT05253755 is a clinical study titled "Study the Safety and Efficacy of DBI-001 Gel Versus Aqueous Gel". The purpose for this study is to assess the Safety and Efficacy of Daily Application for 4 weeks of DBI-001 Gel Versus Aqueous Gel in Subjects with Atopic Dermatitis

What is the current status of trial NCT05253755?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2021-10-06. Estimated completion is 2022-09-09.

What interventions are being tested in trial NCT05253755?

The interventions under investigation include: DBI-001 (BIOLOGICAL), Aqueous gel (BIOLOGICAL).

Who is sponsoring clinical trial NCT05253755?

This trial is sponsored by DermBiont, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05253755's enrollment target sits among peer trials

10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05253755, the US trial registry maintained by the National Library of Medicine. NCT05253755 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.