An open label, single centre, assessor blind pilot study comparing topical tacrolimus 0.1% and hydrocortisone ointment 1% in the treatment of flexural psoriasis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-003835-30-GB

Enrollment

Registered

2005-07-11

Start date

2005-05-26

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

flexural psoriasis

Interventions

Trade Name: Protopic Product Name: Protopic 0.1% (tacrolimus ointment) Pharmaceutical Form: Ointment Trade Name: hydrocortisone 1% (non-proprietary) Product Name: hydrocortisone 1% (non proprietary)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Subjects with diagnosis of flexural psoriasis and aged 18 or above - Subjects who demonstrate willingness to participate in the study and comply with its procedures by signing a written informed consent - women of childbearing potential who are prepared to use an acceptable method of birth control during the study and have a negative urine pregnancy test prior to study entry. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Female subjects who are pregnant or breast feeding. - Subjects who have received treatment for flexural psoriasis 2 weeks prior to study entry. - Subjects currently receiving immunosuppressive drugs. - Subjects who have had a previous reaction to tacrolimus or its constituents - Patient is simultaneously participating in any other clinical trial - any form of substance abuse, psychiatric disorder or condition which may invalidate communication with the investigator.

Design outcomes

Primary

Measure	Time frame
Main Objective: to compare efficacy of tacrolimus ointment 0.1% with hydrocortisone 0.1% ointment;Secondary Objective: to compare the safety of tacrolimus ointment 0.1% with hydrocortisone 0.1%;Primary end point(s): Efficacy will be evaluated by comparing the local psoriasis score indexes recorded at baseline, 4 and 8 weeks for each area treated for the two treatment groups. The affected areas will be assessed for erythema, infiltration and desquamation as follows: 0 - absent; 1 - mild; 2 - moderate; 3 - severe.	—

Measure

Time frame

Main Objective: to compare efficacy of tacrolimus ointment 0.1% with hydrocortisone 0.1% ointment;Secondary Objective: to compare the safety of tacrolimus ointment 0.1% with hydrocortisone 0.1%;Primary end point(s): Efficacy will be evaluated by comparing the local psoriasis score indexes recorded at baseline, 4 and 8 weeks for each area treated for the two treatment groups. The affected areas will be assessed for erythema, infiltration and desquamation as follows: 0 - absent; 1 - mild; 2 - moderate; 3 - severe.

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026