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Trial record 1 of 156 for:    Dermatitis, Atopic, 8
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8-Week Atopic Dermatitis (AD) Treatment Study

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: NCT03386032
Recruitment Status : Completed
First Posted : December 29, 2017
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble

Tracking Information
First Submitted Date  ICMJE December 15, 2017
First Posted Date  ICMJE December 29, 2017
Last Update Posted Date September 6, 2018
Actual Study Start Date  ICMJE November 27, 2017
Actual Primary Completion Date August 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2018)
Severity Scoring of Atopic Dermatitis (SCORAD) [ Time Frame: Baseline to Week 8 ]
SCORAD (Severity Scoring of Atopic Dermatitis) Change from Baseline to Week 8 of atopic dermatitis lesion as measured by the Scoring of Atopic Dermatitis (SCORAD). SCORAD is a composite severity index comprising a) the amount/extent of body area affected; b) 2 subjective symptom visual analog assessments [Itchy 0 (No Itching) to 3 (Severe Itching) and Sleep Disturbance 0 (No Sleep Disturbance) to 3 (Severe Sleep Disturbance)]; and c) 6 disease intensity assessments [Dryness/Scaling, Erythema, Excoriation, Induration/Papulation, Lichenification and Oozing/Weeping/Crusting, each graded from 0 (None) to 3 (Severe). A SCORAD score ranges from 0 (No AD present) to 103 (Severe) SCORAD is calculated: Extent 7*Intensity SCORAD = --------- + ---------------- + Subjective 5 2
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2017)
Severity Scoring of Atopic Dermatitis (SCORAD) [ Time Frame: Baseline to Week 8 ]
SCORAD (Severity Scoring of Atopic Dermatitis) Change from Baseline to Week 8 of atopic dermatitis lesion as measured by SCORAD
Change History Complete list of historical versions of study NCT03386032 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2018)
  • Physician's Global Assessment (PGA) [ Time Frame: Baseline to Week 8 ]
    Change from Baseline to Week 8 of atopic dermatitis lesion as measured by The Physician's Global Assessment (PGA). The PGA is a severity index for dermatological conditions based on a five point scale from 0 (Clear) to 4 (Severe). The physician assesses severity on primary and secondary lesions.
  • Eczema Area and Severity Index (EASI) [ Time Frame: Baseline to Week 8 ]
    Change from Baseline to Week 8 of atopic dermatitis lesion as measured by The Eczema Area and Severity Index (EASI). The EASI is a composite severity index for eczema comprising a) the extent of the body area affected across four body regions (head & neck, trunk, lower extremities, and upper extremities) each graded from 0 (0% affected) to 6 (100% affected) and b) disease severity assessments (Erythema, Lichenification, Edema/Papulation, and Excoriation) each graded from 0 (None) to 3 (Severe). An EASI score ranges from 0 (No Eczema present) to 72 (Severe).
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2017)
  • Physician's Global Assessment (PGA) [ Time Frame: Baseline to Week 8 ]
    Change from Baseline to Week 8 of atopic dermatitis lesion as measured by PGA
  • Eczema Area and Severity Index (EASI) [ Time Frame: Baseline to Week 8 ]
    Change from Baseline to Week 8 of atopic dermatitis lesion as measured by EASI
Current Other Pre-specified Outcome Measures
 (submitted: January 19, 2018)
Dermatology Life Quality Index (DLQI) Improvement [ Time Frame: Baseline to Week 8 ]
Condition improvement from Baseline to Week 8 as measured by the Dermatology Life Quality Index (DLQI). The DLQI is a ten question questionnaire to measure the impact of skin disease on the quality of life for the affected person. Each question is measured on a scale of 0 (no impact) to 3 (large impact). The total score range is 0 (no impact) to 30 (maximum impact).
Original Other Pre-specified Outcome Measures
 (submitted: December 20, 2017)
Quality of Life (QOL) Improvement [ Time Frame: Baseline to Week 8 ]
Condition improvement from Baseline to Week 8 as measured by QoL
 
Descriptive Information
Brief Title  ICMJE 8-Week Atopic Dermatitis (AD) Treatment Study
Official Title  ICMJE 8-Week Atopic Dermatitis (AD) Treatment Study
Brief Summary This is a study to investigate the clinical effectiveness of the Sponsor's experimental cream treatment on eczema as measured by visual grading of SCORAD (scoring of atopic dermatitis).
Detailed Description This will be a 9-week, randomized, double blind, parallel comparison study consisting of a 1-week washout phase followed by an 8-week treatment phase. This study will be executed by one clinical research company utilizing two test sites and up to 62 subjects with moderate or severe atopic dermatitis, ages 12-65, will be enrolled. Subjects that are enrolled will be placed on one of three products (e.g. Sponsor's Experimental Cream Treatment, a basic moisturizer, or a positive control - Desonide) and will be required to use the assigned product twice a day for the duration of the 8-week treatment phase.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Subjects will be randomized and balanced into one of the 3 treatment groups by their baseline SCORAD grade (moderate = 25-40 and severe = 41+) and ethnicity (black or non-black).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
As above
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis Eczema
Intervention  ICMJE
  • Drug: Investigational OTC Cream
    Investigational Over the Counter (OTC) Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.
  • Drug: 0.05% Desonide

    Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.

    Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.

    Other Name: Desowen
  • Other: Placebo Cream
    Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
    Other Name: Vehicle
Study Arms  ICMJE
  • Experimental: Investigational OTC Cream
    Investigational Over the Counter (OTC) Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.
    Intervention: Drug: Investigational OTC Cream
  • Sham Comparator: Placebo Cream
    Placebo Cream will be applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
    Intervention: Other: Placebo Cream
  • Active Comparator: 0.05% Desonide Cream

    Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.

    Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions.

    Interventions:
    • Drug: 0.05% Desonide
    • Other: Placebo Cream
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: September 5, 2018)
65
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2017)
62
Actual Study Completion Date  ICMJE August 18, 2018
Actual Primary Completion Date August 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Is a generally healthy, male or female, 12-65 years old, inclusive;
  • Diagnosis of moderate or greater Atopic Dermatitis as determined by SCORAD (SCORAD >=25);
  • Is able to read and understand instructions in English.

Exclusion Criteria:

  • Is currently participating or has participated in another interventional clinical study in the past 2 weeks;
  • Currently or has been diagnosed or treated for cancer in the past 5 years;
  • Requires any topical or systemic medications that could affect the course of their atopic dermatitis during the study period (except inhaled steroids and/or stable antihistamines for asthma or allergies);
  • Has used systemic treatments that could affect AD within 30 days or 5 half- lives. (i.e. retinoids, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and oral/injectable corticosteroids);
  • Has a known hypersensitivity to any corticosteroid creams;
  • Has been diagnosed with any allergies to Oat or derivatives;
  • Has any active infections or has used antibiotics in the past 7 days;
  • Has any physical attributes or skin conditions that might interfere with the clear visual or instrumental assessments.(i.e. cuts, sunburn, birth marks, tattoos, extensive scarring, excessive hair growth or acne);
  • Has an immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus rheumatoid arthritis) which could place the subject at risk or interfere with the accuracy of the study results;
  • Has used any immunosuppressant drugs or immunotherapy within the past 30days or 5 half-lives;
  • Is an employee of the sponsor company or clinical testing site;
  • Is diabetic;
  • Presents with the presence of an active or chronic allergic reaction as evidenced by an irregular white cell count determined by eosinophils > 0.3 X 109/L at Screening Visit;
  • Is planning a trip to a sunny climate, to use tanning booths or use other UV sources throughout the course of this study;
  • Has a history of hypersensitivity to any substance in investigational preparation or to Desonide;
  • Has any clinically significant medical condition or laboratory abnormality that would, in the opinion of the Investigator, put the patient at undue risk or interfere with the interpretation of the study results;
  • Is dependent on oral medication for any skin disease/condition or could not, in the opinion of the Investigator tolerate the restriction of discontinuing the medicine as required in this study;
  • Is currently pregnant or lactating or planning to become pregnant in the next 6 months;
  • Has other skin conditions that might interfere with AD diagnosis and/or evaluation (i.e. psoriasis current active viral, bacterial and fungal skin infections) as assessed by the Investigator;
  • Any other condition or factor the Investigator or their duly assigned representative believes may affect the ability of the subject to complete the study or the interpretation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 65 Years   (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 NCT03386032
Other Study ID Numbers  ICMJE CSD2017168
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Procter and Gamble
Study Sponsor  ICMJE Procter and Gamble
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Procter and Gamble
Verification Date September 2018

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