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A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD)

An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults With Mild to Moderate Atopic Dermatitis

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02376049
Enrollment
30
Registered
2015-03-03
Start date
2015-02-28
Completion date
2015-07-31
Last updated
2025-02-24

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

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis, Eczema, AD

Brief summary

An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults with Mild to Moderate Atopic Dermatitis.

Detailed description

Multi-center, prospective, randomized, vehicle-controlled, investigator-blinded, stable lesion design.

Interventions

DRUGClobetasol propionate cream
DRUGGlaxal Base cream vehicle

Sponsors

LEO Pharma
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Subject with mild to moderate AD * Four comparable TAs * TSS of at least 5 on all TAs * Difference in TSS not greater than 2 between the TAs * Sign score erythema ≥ 2 between the TAs * TAs should be at least 2 cm apart

Exclusion criteria

* Investigator's opinion * Fitzpatrick skin type \>5 * Topical (i.e. on the TAs) treatment with prohibited medications * Systemic treatment with prohibited medications * Phototherapy within prohibited timeframe * Use of emollients within prohibited timeframe

Design outcomes

Primary

MeasureTime frameDescription
Total Sign Score (TSS) change14 daysTSS change at end of treatment in relation to baseline

Countries

Canada, Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026