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NCT03089229

A Study to Evaluate the Efficacy and Safety of HAT01H in Atopic Dermatitis

Completed Phase 1, PHASE2 Last updated 7 November 2018
What this trial tests

Phase 1, PHASE2 trial testing HAT01H Cream in Atopic Dermatitis in 30 participants. Completed in 31 July 2017.

Timeline
26 March 2017
Primary endpoint
30 June 2017
31 July 2017

Quick facts

Lead sponsorHaus Bioceuticals
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment30
Start date26 March 2017
Primary completion30 June 2017
Estimated completion31 July 2017
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

Haus Bioceuticals — full company profile →

Who can join

Adults 12 to 65, any sex, with Atopic Dermatitis or Eczema. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by a disturbance of epidermal-barrier function that results in intensely pruritic subacute and chronic eczematous plaques. The current therapy of AD is reactive, where the flares are treated through symptomatic management with topical corticosteroids and calcineurin inhibitors. Given that these medications have long-term side-effects, and given the chronically relapsing immunopathogenic nature of AD, there is an imperative need for safer anti-inflammatory medications. Haus Bioceuticals (Haus) has developed a novel topical treatment for eczema/atopic dermatitis (AD) denoted HAT01H, and have demonstrated that HAT01H is safe and profoundly effective in the treatment of AD, controlling signs and symptoms in 85% of patients with AD. This study is aimed to further test the efficacy and safety of topical HAT01H in patients with moderate to severe atopic dermatitis.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. New and Upcoming Topical Treatments for Atopic Dermatitis: A Review of the Literature.
    Sideris N, Paschou E, Bakirtzi K, Kiritsi D, et al · · 2022 · cited 28× · PMID 36078904 · DOI 10.3390/jcm11174974
  2. Topical anti-inflammatory treatments for eczema: network meta-analysis.
    Lax SJ, Van Vogt E, Candy B, Steele L, et al · · 2024 · cited 22× · PMID 39105474 · DOI 10.1002/14651858.cd015064.pub2

Verify or expand the search:

Other recruiting trials for Atopic Dermatitis

Currently open trials in the same condition.

Other Haus Bioceuticals trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03089229.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing