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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02376049
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Pimecrolimus cream Drug: Betamethasone dipropionate cream Drug: Clobetasol propionate cream Drug: Glaxal Base cream vehicle Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults With Mild to Moderate Atopic Dermatitis
Study Start Date : February 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Active Comparator: Pimecrolimus cream
Pimecrolimus 1% cream once daily for 14 days
Drug: Pimecrolimus cream
Other Name: Elidel

Active Comparator: Betamethasone dipropionate cream
Betamethasone dipropionate 0.05% cream once daily for 14 days
Drug: Betamethasone dipropionate cream
Other Names:
  • Diprosone
  • Diprolene

Active Comparator: Clobetasol propionate cream
Clobetasol propionate 0.05% cream once daily for 14 days
Drug: Clobetasol propionate cream
Other Name: Dermovate

Placebo Comparator: Glaxal Base cream vehicle
Glaxal Base cream vehicle once daily for 14 days
Drug: Glaxal Base cream vehicle
Other Name: emollient cream




Primary Outcome Measures :
  1. Total Sign Score (TSS) change [ Time Frame: 14 days ]
    TSS change at end of treatment in relation to baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376049


Locations
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Canada, Quebec
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2K 4L5
Israel
Beit Harofim
Netanya, Israel, 42701
Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: Emma Guttmann, MD Icahn School of Medicine
Additional Information:
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02376049    
Other Study ID Numbers: EXP-1184
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Keywords provided by LEO Pharma:
Atopic Dermatitis
Eczema
AD
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Clobetasol
Pimecrolimus
Emollients
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents