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Comparison of the atrophogenic effect of hydrocortisone 1% cream and Elidel (Pimecrolimus 1% cream) assessed by Optical Coherence Tomography (OCT) and 20-MHZ ultrasound of uninvolved skin in patients with atopic dermatitis - OCT-AD-Study

Comparison of the atrophogenic effect of hydrocortisone 1% cream and Elidel (Pimecrolimus 1% cream) assessed by Optical Coherence Tomography (OCT) and 20-MHZ ultrasound of uninvolved skin in patients with atopic dermatitis - OCT-AD-Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-004279-20-DE
Enrollment
20
Registered
2009-07-30
Start date
2007-11-14
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

patients with mild to moderate atopic dermatitis not affecting the test areas

Interventions

Trade Name: Elidel 1% Creme Pharmaceutical Form: Cream INN or Proposed INN: Pimecrolimus Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 10- Trade Name: Hyd

Sponsors

Technical University Dresden
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Age 18 -60 years - Diagnoses of atopic dermatitis (Hanifin & Rajka Criteria) - patients with atopic dermatitis not affecting the forehead 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: - pregnancy / nursing mothers - women in reproductive age without adequate contraception - Severe atopic dermatitis (IGA >= 4) - UV-Therapy in past 4 weeks - Patients receiving any topical treatment on the face in past 6 month

Design outcomes

Primary

MeasureTime frame
Main Objective: To explore the atrophogenic potentials of hydrocortisone 1% cream and Pimecrolimus 1% cream on unaffected forehead skin for 4 weeks;Secondary Objective: Comparison of OCT and 20-MHz ultrasound as tools to assess epidermal and/or dermal thinning induced by topical treatment with hydrocortisone 1% cream or Pimecrolimus 1% cream, respectively;Primary end point(s): - thickness of epidermis - thickness of dermis—

Countries

Germany

Outcome results

None listed

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