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

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: NCT02153762
Recruitment Status : Completed
First Posted : June 3, 2014
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE May 27, 2014
First Posted Date  ICMJE June 3, 2014
Last Update Posted Date April 13, 2017
Study Start Date  ICMJE April 2013
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02153762 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2014)
  • 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.
  • Change from Baseline Pruritus at Day 29 [ Time Frame: baseline and Day 29 ]
    Change from baseline pruritus at day 29
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Atopic Dermatitis With Different Orders of Application of Locoid Lotion and Hylatopic Plus Cream
Official Title  ICMJE Assessment of Application Order When Utilizing Locoid Lotion and Hylatopic Plus Cream in the Treatment of Atopic Dermatitis
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • 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 Name: 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 Name: Topical skin barrier repair therapies (BRT)
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Locoid Lipocream
    • Drug: Hylatopic Plus
  • 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.
    Interventions:
    • Drug: Locoid Lipocream
    • Drug: Hylatopic Plus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2014)
41
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02153762
Other Study ID Numbers  ICMJE GCO 12-1932
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joshua Zeichner, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP