Phase 3 N=326 Randomized Single-blind Treatment

Clobetasol Propionate 0.05% Shampoo in Association With Antifungal Shampoo in Scalp Seborrheic Dermatitis

Scalp Seborrheic Dermatitis

Bottom Line

View on ClinicalTrials.gov: NCT00862654 ↗

Enrolled (actual)

326

Serious AEs

0.6%

Results posted

Aug 2011

Primary outcome: Primary: Total Severity Score (TSS): Percent Change From Baseline at Week 4 — -71.4; -66.7; -66.7; -57.1 Percent change — p=<0.01

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week) (Drug); clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week) (Drug); clobetasol propionate shampoo (2/week) (Drug); ketoconazole shampoo (2/week) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Feb 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Severity Score (TSS): Percent Change From Baseline at Week 4	-71.4; -66.7; -66.7; -57.1	<0.01 sig

Summary

The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in the treatment of scalp Seborrheic Dermatitis.

Eligibility Criteria

Inclusion Criteria

Subjects with moderate to severe scalp Seborrheic Dermatitis

Exclusion Criteria

Subjects suffering from psoriasis,
Subjects with a known allergy to one of the components of the test products,
Female subjects who are pregnant, nursing or planning a pregnancy during the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00862654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.