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

NCT02376049 — Phase 1, Completed, 30 participants, LEO Pharma

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

Registry	NCT02376049
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, single group, masking: double, treatment
Enrollment	30 (Actual)
Sponsor	LEO Pharma (Industry)
Conditions	Atopic Dermatitis
Interventions	Pimecrolimus cream, Betamethasone dipropionate cream, Clobetasol propionate cream, Glaxal Base cream vehicle (Drug)
Dates	start 2015-02-01, primary completion 2015-07-01, completion 2015-07-01, first posted 2015-03-03, last updated 2025-02-24
Locations	2 sites in Canada, Israel

-Summary

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

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+Detailed description

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

+Arms and interventions

Arm	Type	Interventions	Description
Pimecrolimus cream	Active comparator	Drug: Pimecrolimus cream	Pimecrolimus 1% cream once daily for 14 days
Betamethasone dipropionate cream	Active comparator	Drug: Betamethasone dipropionate cream	Betamethasone dipropionate 0.05% cream once daily for 14 days
Clobetasol propionate cream	Active comparator	Drug: Clobetasol propionate cream	Clobetasol propionate 0.05% cream once daily for 14 days
Glaxal Base cream vehicle	Placebo comparator	Drug: Glaxal Base cream vehicle	Glaxal Base cream vehicle once daily for 14 days

Pimecrolimus cream (Drug), also known as Elidel
Betamethasone dipropionate cream (Drug), also known as Diprosone, Diprolene
Clobetasol propionate cream (Drug), also known as Dermovate
Glaxal Base cream vehicle (Drug), also known as emollient cream

+Outcome measures

Primary outcomes

Total Sign Score (TSS) change [14 days]: TSS change at end of treatment in relation to baseline

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (2)

Facility	City	Country	Status
Innovaderm Research Inc.	Montreal, Quebec	Canada
Beit Harofim	Netanya	Israel

+Investigators

Emma Guttmann, MD, Principal investigator, Icahn School of Medicine