Treatment of Atopic Dermatitis With Different Orders of Application of Locoid Lotion and Hylatopic Plus Cream

April 11, 2017 updated by: Icahn School of Medicine at Mount Sinai

Assessment of Application Order When Utilizing Locoid Lotion and Hylatopic Plus Cream in the Treatment of Atopic Dermatitis

The purpose of this study is to evaluate the safety and tolerability, as well as effectiveness, with regards to the order of application for Locoid Lipocream and Hylatopic Plus cream in patients with atopic dermatitis (AD), which is a type of skin rash.Topical skin barrier repair therapies (BRT) that are plain moisturizing creams/lotions with added lipids (fats/oils), such as Hylatopic Plus cream, have emerged as an effective addition to the the treatment of atopic dermatitis. BRTs are often used along with topical steroids (medicated creams), such as Locoid lotion, on skin with AD, and as a monotherapy (single treatment) on both non-diseased and diseased skin. Since BRTs help to restore components of skin that are absent in skin with AD, it is believed that long-term BRT use may reduce further development of further AD. This is an open-label, single site study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • subjects of at least 3 months of age.
  • clinical diagnosis of stable mild to moderate AD using the Hanifin and Rajka criteria for diagnosing AD
  • AD lesions of similar size and severity of bilateral anatomic location
  • a SPGA score of 2 or 3 and at least 10% BSA involvement at baseline
  • in good health, without evidence of disease process(es) that would present patient safety concerns or confounding factors for assessment of study objectives
  • able and willing to understand and sign an informed consent (or if applicable parent or legal guardian sign an informed consent),
  • able and willing to agree to requirements and restrictions of the study
  • Subjects who are willing to discontinue all systemic corticosteroids, immunomodulators, ultra violet light therapy or other medication (investigational or otherwise) that may have an effect on atopic dermatitis disease progression for 30 days prior to the baseline measurement.
  • Subjects on a stable maintenance therapy (at least 30 days of use prior to baseline) of antihistamines and/or nasal spray containing corticosteroids for the treatment of bronchial asthma or allergic rhinitis, and antibiotics for the treatment of acne will be allowed.
  • Subjects who are willing to discontinue use of topical treatments for AD including, but not limited to, corticosteroids, immunomodulators, vitamin D treatments, retinoids, topical antihistamines for at least 14 days prior to baseline
  • Subjects who are willing to discontinue use of oral antibiotic therapy for at least 7 days prior to baseline, unless prescribed for acne treatment as previously described
  • Subjects with no known allergy to any of the study product ingredients
  • Women of childbearing potential must be willing to use a form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, Norplant, Depo-Provera, double barrier methods (e.g., condom and spermicide) and abstinence.

Exclusion Criteria:

  • immunocompromised patients, or subjects with extensive disease that could not reasonably be controlled with topical therapy
  • history or evidence of other conditions that would interfere with the evaluation of the study medication
  • subjects desiring excessive or prolonged exposure to UV light (e.g. sunlight/tanning beds) during the study
  • Use of topical medications for AD or any other medical condition.
  • Subjects currently involved in another clinical research study.
  • Subjects, who are pregnant, breast feeding or planning a pregnancy.
  • Subjects with clinically significant unstable medical or mental disorders.
  • Subjects who are unwilling or unable to comply with the requirements of the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Right side
Patients were randomized to apply Locoid Lipocream on the right side of the target lesion followed by Hylatopic Plus lotion on the left side of the target lesion with the reverse order on the other side.
Drug: Locoid Lipocream
Patients were randomized to apply Locoid Lipocream followed by Hylatopic Plus lotion on either the right or left side target lesion with the reverse order on the other side.
Other Names:
  • Topical skin barrier repair therapies (BRT)
Drug: Hylatopic Plus
Patients were randomized to apply Locoid Lipocream followed by Hylatopic Plus lotion on either the right or left side target lesion with the reverse order on the other side.
Other Names:
  • Topical skin barrier repair therapies (BRT)
Active Comparator: Left first
Patients were randomized to apply Locoid Lipocream on the left side of the target lesion followed by Hylatopic Plus lotion on the right side of the target lesion with the reverse order on the other side.
Drug: Locoid Lipocream
Patients were randomized to apply Locoid Lipocream followed by Hylatopic Plus lotion on either the right or left side target lesion with the reverse order on the other side.
Other Names:
  • Topical skin barrier repair therapies (BRT)
Drug: Hylatopic Plus
Patients were randomized to apply Locoid Lipocream followed by Hylatopic Plus lotion on either the right or left side target lesion with the reverse order on the other side.
Other Names:
  • Topical skin barrier repair therapies (BRT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Treatment Success at Day 29
Time Frame: baseline and Day 29
Treatment Success defined as Clear or Almost Clear (0 or 1) on the 5 point static physician global assessment of psoriasis (SPGA) scale at day 29, evaluating non-inferiority of one group compared to the other using the lower limit of the confidence interval for the difference in success proportions, as compared to baseline.
baseline and Day 29

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline SPGA scale at Day 29
Time Frame: baseline and Day 29
2 point reduction of SPGA at day 29 as compared to baseline. The sPGA is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity.
baseline and Day 29
Change from Baseline Pruritus at Day 29
Time Frame: baseline and Day 29
Change from baseline pruritus at day 29
baseline and Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

May 27, 2014

First Submitted That Met QC Criteria

May 29, 2014

First Posted (Estimate)

June 3, 2014

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 12-1932

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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