NCT00689832 is a Phase 4 clinical trial of Tacrolimus 0.03% in Dermatitis, Atopic, sponsored by Astellas Pharma Inc.

Who is sponsoring NCT00689832?

NCT00689832 is sponsored by Astellas Pharma Inc.

What drugs are being tested in NCT00689832?

Interventions in NCT00689832: Tacrolimus 0.03%, Fluticasone 0.005%.

What condition does NCT00689832 study?

NCT00689832 studies Dermatitis, Atopic.

Is NCT00689832 still recruiting?

NCT00689832 is currently completed. Last updated 28 August 2014.

Last reviewed 2014-08-28 · How we verify

NCT00689832

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Comparative, Multicentre, Randomised, Double-blind Study to Assess the Efficacy of Tacrolimus 0.03% Ointment Versus Fluticasone 0.005% Ointment in Children Aged 2 Years or Over Suffering From Moderate to Severe Atopic Dermatitis.

Completed Phase 4 Last updated 28 August 2014

What this trial tests

Phase 4 trial testing Tacrolimus 0.03% in Dermatitis, Atopic in 487 participants. Completed in 1 August 2005.

Timeline

1 February 2004

Primary endpoint
1 August 2005

1 August 2005

Quick facts

Lead sponsor	Astellas Pharma Inc
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	487
Start date	1 February 2004
Primary completion	1 August 2005
Estimated completion	1 August 2005
Sites	1 location across France

Drugs / interventions tested

Tacrolimus 0.03%
Fluticasone 0.005% — full drug profile →

Conditions studied

Dermatitis, Atopic — all drugs for Dermatitis, Atopic →

Sponsor

Astellas Pharma Inc — full company profile →

Who can join

Adults 2 to 15, any sex, with Dermatitis, Atopic. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percentage of patients presenting at the week 3 visit (day 21) with an improvement of at least 60% in their modified Eczema Area and Severity Index (mEASI) in comparison to day 1
Time frame: 3 weeks

Sponsor's own description

Children with atopic eczema and a poor response to topical corticosteroid applied either Protopic or Fluticasone ointment twice a day for 3 weeks. They could continue during 3 more weeks once a day if needed.

Publications & conference data

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

Strategies for using topical corticosteroids in children and adults with eczema.
Lax SJ, Harvey J, Axon E, Howells L, et al · · 2022 · cited 38× · PMID 35275399 · DOI 10.1002/14651858.cd013356.pub2
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 Dermatitis, Atopic

Currently open trials in the same condition.

NCT07230860 — A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis · Phase 2 · recruiting
NCT06899204 — Real World Efficiency of Abrocitinib Treatment at Patients With Moderate to Severe Atopic Dermatitis Who Had Inadequate · recruiting
NCT07042126 — Evaluation of 611 in Chinese Adolescents With Moderate to Severe Atopic Dermatitis · Phase 3 · recruiting
NCT06881251 — A Study of JNJ-95475939 in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (AD) · Phase 2 · active not recruiting
NCT06554847 — Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Severe Atopic Dermatitis · Phase 3 · active not recruiting

Other Astellas Pharma Inc trials

Trials by the same sponsor.

NCT07318714 — A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke · Phase 1, PHASE2 · recruiting
NCT07094204 — A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors · Phase 1 · recruiting
NCT06970665 — A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Ma · Phase 4 · recruiting
NCT06364696 — A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors · Phase 1 · active not recruiting
NCT06206421 — A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00689832 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Astellas Pharma Inc
Last refreshed: 28 August 2014

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/NCT00689832.

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