8-Week Atopic Dermatitis (AD) Treatment Study

NCT03386032 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CSD2017168
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

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).

Conditions

Atopic Dermatitis Eczema

Outcome Measures

Primary Outcomes (2)

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

  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

  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

Study Arms (3)

Investigational OTC Cream

EXPERIMENTAL

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

Placebo Cream

SHAM COMPARATOR

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

0.05% Desonide Cream

ACTIVE COMPARATOR

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; Other: Placebo Cream

Interventions

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.

Investigational OTC Cream

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.

Also known as: Desowen

0.05% Desonide Cream

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.

Also known as: Vehicle

0.05% Desonide Cream; Placebo Cream

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (2)

Wake Research, LLC

Raleigh, North Carolina, 27612, United States

Location

WR (Wake Research) ClinSearch

Chattanooga, Tennessee, 37421, United States

Location

MeSH Terms

Interventions

Desonide

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Laurie Moulton, M.S., Statistical Group Scientist
• Organization: The Procter & Gamble Company

moulton.lt@pg.com

+1-513-544-3636

Study Officials

• Amanda Salisbury, BSN

  Wake Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: As above
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 29, 2017
• Study Start: November 27, 2017
• Primary Completion: August 18, 2018
• Study Completion: August 18, 2018
• Last Updated: December 17, 2020
• Results First Posted: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)