Efficacy and Safety Study of MSRD-100 in Subjects With Atopic Dermatitis >=3 Months of Age and Older

Atopic Dermatitis Clinical Trial

— MSRD-100  

Official title:

A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of MSRD-100 in Subjects >=3 Months of Age With Atopic Dermatitis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02677610
• Other study ID #: M169981001
• Status: Withdrawn
• Phase: Phase 3
• First received: January 27, 2016
• Last updated: September 8, 2016
• Est. completion date: March 2017

Study information

• Verified date: September 2016
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a double-blind, randomized, vehicle-controlled, multi-center, parallel group Phase 3 study of MSRD-100 in the treatment of atopic dermatitis in subjects aged 3 months and up.

Description:

This is a 4-week efficacy, safety and tolerability study of MSRD-100 applied twice daily for 4 weeks compared to its vehicle among subjects ≥3 months of age in the treatment of atopic dermatitis covering ≥5% body surface area.

The study will consist of up to 4 visits which includes Screening - Visit 1 (Screening), Baseline - Visit 2 , Visit 3 (Day 14), and an End of Treatment/Final Study Visit - Visit 4 (Day 28).

Study IDs M169981001 and M169981002 are two identical studies being run in parallel with different study sites.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months and older

Eligibility

Key Inclusion Criteria:

1. Subjects who are male or female, =3 months of age on the date of Baseline Visit.

2. Subjects with a diagnosis of atopic dermatitis, active inflammation and meeting the Hanifin and Rajka Diagnosis Criteria for Atopic Dermatitis.

3. Subjects must have an Investigator Global Assessment (IGA) score of =2 at baseline.

4. Subjects who have atopic dermatitis covering =5% Body Surface Area (BSA) excluding the eyelids, perioral area, around the nostrils, and in the diaper area (for subjects who wear diapers or plastic pants).

5. Subjects who have atopic dermatitis with a sign and symptom score = 2 on the following three signs and symptoms: erythema, infiltration/papulation, and erosion/oozing/crusting present in at least one body surface area affected.

Key Exclusion Criteria:

1. Unstable course of Atopic Dermatitis (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to baseline.

2. Concurrent conditions and history of other diseases.

3. Used any of the following treatments within the indicated washout period before the baseline visit or those who would require the following during the study.

4. Subjects who require treatment with any other topical or systemic therapy for the study disease other than bland emollients in untreated areas of disease.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• MSRD-100
MSRD-100 is a topical gel.
• Vehicle
Vehicle is a topical gel without the active ingredient in MSRD-100

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the proportion of subjects with treatment success in the MSRD-100 and vehicle group	Treatment success is defined as an Investigator Global Assessment (IGA) score of clear or almost clear and a minimum of a 2-grade improvement in IGA score from baseline plus no worsening on any of the signs present at baseline.; The primary endpoint is a composite of: (1) the IGA score of clear or almost clear as well as subjects having a minimum two point improvement on the IGA, plus (2) no worsening of any of the signs present at baseline.	Visit 4 (Day 28)	No
Secondary	Compare the proportion of subjects with an IGA score of 0 or 1 between the MSRD-100 and vehicle at Visit 4		Visit 4 (Day 28)	No