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Completed

NCT Number: NCT03386032

8-Week Atopic Dermatitis (AD) Treatment Study

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).

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Key information

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Wake Research, LLC, Raleigh, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Investigational OTC Cream

Drug

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.

0.05% Desonide

Drug

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 names: Desowen

Placebo Cream

Other

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 names: Vehicle

Primary outcomes

  1. Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Moderate Atopic Dermatitis

    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)b) 2 subjective symptom of pruritus (10 pts VAS) and sleep disturbance measured (10 pts VAS); and c) 6 disease intensity assessments [Dryness/Scaling, Erythema, Excoriation, Induration/Papulation, Lichenification and Oozing/ Weeping/Crusting, each graded in 3pts TIS from 0 (None) to 3 (Severe). A SCORAD score ranges from 0 (No AD present) to 103

    SCORAD is calculated:

    Extent 7*Intensity SCORAD = --------- + ---------------- + Subjective 5 2

  2. Severity Scoring of Atopic Dermatitis (SCORAD) Amongst Subjects With Severe Atopic Dermatitis

    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)b) 2 subjective symptom of pruritus (10 pts VAS) and sleep disturbance measured (10 pts VAS); and c) 6 disease intensity assessments [Dryness/Scaling, Erythema, Excoriation, Induration/Papulation, Lichenification and Oozing/ Weeping/Crusting, each graded in 3pts TIS from 0 (None) to 3 (Severe). A SCORAD score ranges from 0 (No AD present) to 103

    SCORAD is calculated:

    Extent 7*Intensity SCORAD = --------- + ---------------- + Subjective 5 2

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2017
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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