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8-Week Atopic Dermatitis (AD) Treatment Study

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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

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).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Drug: Investigational OTC Cream Drug: 0.05% Desonide Other: Placebo Cream Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
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
Official Title: 8-Week Atopic Dermatitis (AD) Treatment Study
Actual Study Start Date : November 27, 2017
Actual Primary Completion Date : August 18, 2018
Actual Study Completion Date : August 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Desonide

Arm Intervention/treatment
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.
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.

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.
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

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.

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




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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.

  2. 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).


Other Outcome Measures:
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03386032


Locations
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United States, North Carolina
Wake Research, LLC
Raleigh, North Carolina, United States, 27612
United States, Tennessee
WR (Wake Research) ClinSearch
Chattanooga, Tennessee, United States, 37421
Sponsors and Collaborators
Procter and Gamble

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Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT03386032     History of Changes
Other Study ID Numbers: CSD2017168
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
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
Desonide
Anti-Inflammatory Agents