Trial · NCT00862654

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

NCT00862654, Phase 3, Completed, Galderma R&D; results first posted 2011-08-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clobetasol Propionate 0.05% Shampoo in Association With Antifungal Shampoo in Scalp Seborrheic Dermatitis. Trials, record NCT00862654. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00862654

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Clobetasol Propionate 0.05% Shampoo in Association With Antifungal Shampoo in Scalp Seborrheic Dermatitis
NCT number: NCT00862654
Status: Completed
Phases: Phase 3
Enrollment: 326 participants, actual
Lead sponsor: Galderma R&D
Conditions: Scalp Seborrheic Dermatitis
Interventions: clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week), clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week), clobetasol propionate shampoo (2/week), ketoconazole shampoo (2/week)
First posted: 2009-03-17
Last updated: 2021-02-18
Results first posted: 2011-08-12

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Total Severity Score (TSS): Percent Change From Baseline at Week 4	baseline and week 4	Total Severity Score (TSS) is sum of erythema, scaling and pruritus severity scores of the lesions evaluated each on a 4-point scale from 0 = None to 3 = Severe by the investigator. So minimum TSS can be 0 and maximum 9.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Total Severity Score (TSS): Percent Change From Baseline at Week 4	baseline and week 4	Intent To Treat (ITT) with Last Observation Carried Forward (LOCF)	Percent change	MEDIAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Total Severity Score (TSS): Percent Change From Baseline at Week 4	C Propionate 4/Week + Ketoconazole 2/Week	-71.4	Full Range -100 to 14.3	Percent change
Total Severity Score (TSS): Percent Change From Baseline at Week 4	C Propionate 2/Week + Ketoconazole 2/Week	-66.7	Full Range -100 to 0	Percent change
Total Severity Score (TSS): Percent Change From Baseline at Week 4	C Propionate 2/Week	-66.7	Full Range -100 to 0	Percent change
Total Severity Score (TSS): Percent Change From Baseline at Week 4	Ketakonazol 2/Week	-57.1	Full Range -100 to 33.3	Percent change

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	C Propionate 4/Week + Ketoconazole 2/Week	82
Overall Study	STARTED	C Propionate 2/Week + Ketoconazole 2/Week	82
Overall Study	STARTED	C Propionate 2/Week	82
Overall Study	STARTED	Ketakonazol 2/Week	80
Overall Study	COMPLETED	C Propionate 4/Week + Ketoconazole 2/Week	76
Overall Study	COMPLETED	C Propionate 2/Week + Ketoconazole 2/Week	74
Overall Study	COMPLETED	C Propionate 2/Week	76
Overall Study	COMPLETED	Ketakonazol 2/Week	74
Overall Study	NOT COMPLETED	C Propionate 4/Week + Ketoconazole 2/Week	6
Overall Study	NOT COMPLETED	C Propionate 2/Week + Ketoconazole 2/Week	8

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events52

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dermatitis Acneiform	Skin and subcutaneous tissue disorders	C Propionate 4/Week + Ketoconazole 2/Week	1	82	1
other	Dermatitis Acneiform	Skin and subcutaneous tissue disorders	C Propionate 2/Week + Ketoconazole 2/Week	1	82	1
other	Dermatitis Acneiform	Skin and subcutaneous tissue disorders	C Propionate 2/Week	2	82	2
other	Dermatitis Acneiform	Skin and subcutaneous tissue disorders	Ketakonazol 2/Week	1	80	1
other	Dengue fever	Infections and infestations	C Propionate 4/Week + Ketoconazole 2/Week	0	82	0
other	Dengue fever	Infections and infestations	C Propionate 2/Week + Ketoconazole 2/Week	0	82	0
other	Dengue fever	Infections and infestations	C Propionate 2/Week	2	82	2
other	Dengue fever	Infections and infestations	Ketakonazol 2/Week	0	80	0
other	Dymenorrhoea	Reproductive system and breast disorders	C Propionate 4/Week + Ketoconazole 2/Week	2	82	3
other	Dymenorrhoea	Reproductive system and breast disorders	C Propionate 2/Week + Ketoconazole 2/Week	0	82	0

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	C Propionate 4/Week + Ketoconazole 2/Week
Total, all-cause mortality	C Propionate 2/Week + Ketoconazole 2/Week
Total, all-cause mortality	C Propionate 2/Week
Total, all-cause mortality	Ketakonazol 2/Week
Total, other adverse events	C Propionate 4/Week + Ketoconazole 2/Week	15	82
Total, other adverse events	C Propionate 2/Week + Ketoconazole 2/Week	18	82
Total, other adverse events	C Propionate 2/Week	17	82
Total, other adverse events	Ketakonazol 2/Week	16	80
Total, serious adverse events	C Propionate 4/Week + Ketoconazole 2/Week	1	82
Total, serious adverse events	C Propionate 2/Week + Ketoconazole 2/Week	0	82

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21707573	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00862654

GET https://conductscience.org/api/trials/v1/NCT00862654/events?page=2

API reference For AI assistants