Safety and Efficacy Study in Subjects With Seborrheic Dermatitis

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01703793

Enrollment

240

Registered

2012-10-11

Start date

2012-09-30

Completion date

2013-01-31

Last updated

2013-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seborrheic Dermatitis

Brief summary

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

Interventions

DRUGTest Product 49778

DRUGTest Product 10156

DRUGVehicle (placebo)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Symptom Improvement (investigator assessment)	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

Measure	Time frame	Description
Symptom Improvement (subject assessment)	Weeks 2 and 4	Assess the change in the pruritus score from baseline to week 2 and to week 4.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026