Safety and Efficacy Study in Subjects With Seborrheic Dermatitis

Seborrheic Dermatitis Clinical Trial

Official title:

A Parallel-group, Vehicle-controlled, Randomized, Double-blind Study of the Efficacy and Safety of Product 49778 and Product 10156 in Subjects With Seborrheic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01703793
• Other study ID #: MP-1001-01
• Status: Completed
• Phase: Phase 2
• First received: October 7, 2012
• Last updated: January 7, 2013
• Start date: September 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Medicis Global Service Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if two test products are safe and effective in the treatment of seborrheic dermatitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Investigator assessment of seborrheic dermatitis.

• Additional criteria as identified in the protocol.

Exclusion Criteria:

• History of or ongoing psoriasis of the scalp.

• History of or ongoing atopic dermatitis of the scalp.

• Additional criteria as identified in the protocol.

Study Design

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Seborrheic
• Eczema
• Seborrheic Dermatitis

Intervention

Drug:
• Test Product 49778

• Test Product 10156

• Vehicle (placebo)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medicis Global Service Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom Improvement (investigator assessment)	Proportion of subjects with a response of clear or almost clear, and at least a two-grade improvement from baseline to week 4	Week 4	No
Secondary	Symptom Improvement (subject assessment)	Assess the change in the pruritus score from baseline to week 2 and to week 4.	Weeks 2 and 4	No