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Completed

NCT Number: NCT01703793

Safety and Efficacy Study in Subjects With Seborrheic Dermatitis

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

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Key information

Conditions

Seborrheic Dermatitis Dermatitis Dermatitis, Seborrheic Sebaceous Gland Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fremont, California, United States

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Test Product 49778

Drug

Test Product 10156

Drug

Vehicle (placebo)

Drug

Primary outcomes

  1. Symptom Improvement (investigator assessment)

    Time frame: Week 4

    Proportion of subjects with a response of clear or almost clear, and at least a two-grade improvement from baseline to week 4

Secondary outcomes

  1. Symptom Improvement (subject assessment)

    Time frame: Weeks 2 and 4

    Assess the change in the pruritus score from baseline to week 2 and to week 4.

Sponsors and collaborators

Lead sponsor

Medicis Global Service Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 11, 2012
Registry last updated
Jan 9, 2013

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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