- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03386032
8-Week Atopic Dermatitis (AD) Treatment Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
North Carolina
-
Raleigh, North Carolina, United States, 27612
- Wake Research, LLC
-
-
Tennessee
-
Chattanooga, Tennessee, United States, 37421
- WR (Wake Research) ClinSearch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
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.
|
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:
|
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. |
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:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
Baseline to Week 8
|
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 |
Baseline to Week 8
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Amanda Salisbury, BSN, Wake Research, LLC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSD2017168
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Atopic Dermatitis Eczema
-
University of California, DavisCompletedAtopic Dermatitis | Hand Eczema | Atopic Eczema | Infantile EczemaUnited States
-
Jacob Pontoppidan ThyssenThe Novo Nordic FoundationRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis FlareDenmark
-
Kari NadeauKing's College London; National Institute of Allergy and Infectious Diseases... and other collaboratorsRecruitingEczema | Atopic Dermatitis | Atopic Dermatitis Eczema | Eczema, InfantileUnited States, United Kingdom
-
Catalysis SLCompletedAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related Conditions | Atopic Dermatitis \(AD\)Serbia
-
Petra LarmoCliniscan LtdTerminated
-
Groningen Research Institute for Asthma and COPDNumico Research Wageningen, the NetherlandsCompletedAtopic Dermatitis | Atopic Eczema | Infantile EczemaNetherlands
-
PfizerActive, not recruitingEczema | Atopic Dermatitis | Eczema, Atopic | Atopic Dermatitis, UnspecifiedUnited States, Canada, Czechia, Poland
-
ShaperonRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis of ScalpUnited States
-
University of California, San FranciscoSanofi; Regeneron PharmaceuticalsRecruitingEczema | Atopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related ConditionsUnited States
-
University College CorkCompletedEczema | Food Allergy | Eczema, Infantile | Eczema Atopic DermatitisIreland
Clinical Trials on Investigational OTC Cream
-
Procter & Gamble BeautyCompletedEczema | Dermatitis, AtopicUnited States
-
Johnson & Johnson Consumer Inc. (J&JCI)Completed
-
GlaxoSmithKlineWithdrawnDenture RetentionUnited States
-
Scientific Laboratory Products, Ltd.Completed
-
Hadassah Medical OrganizationUnknown
-
Erchonia CorporationCompleted
-
Pacific UniversityGunnar OptiksTerminatedDry Eye | Visual Acuity | Color Perception | Eye Strain | ReadingUnited States
-
University of FloridaNext Science LLCCompleted
-
University of Texas Southwestern Medical CenterCompletedKeratoconjunctivitis SiccaUnited States
-
SeqirusCompletedInfluenzaAustralia, New Zealand, Philippines, South Africa