Phase 4
Completed N=58
Evaluation of the Efficacy and Tolerability of Clobetasol Propionate Foam Compared to Vehicle Foam
Source: ClinicalTrials.gov NCT00842153 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcomePrimary: Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4 — 6; 2; 19; 3 participants — p=0.1269
Summary
The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4 |
6; 2; 19; 3; 12; 2 | 0.1269 |
| SECONDARY Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4 |
19; 6; 21; 9; 15; 8 | — |
| SECONDARY Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2 |
21; 17 | — |
| SECONDARY Number of Participants With an Erythema Score of 0 or 1 at Week 2 |
6; 1 | — |
| SECONDARY Number of Participants With a Scaling Score of 0 or 1 at Week 2 |
11; 5 | — |
| SECONDARY Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2 |
16; 4 | — |
| SECONDARY Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Week 2 |
5; 1 | — |
| SECONDARY Mean Percent Change From Baseline to Week 2 in Pruritus (Target Lesion) |
-30.5; 40.1 | — |
| SECONDARY Mean Percent Change From Baseline to Week 2 in Percent (%) of Body Surface Area (BSA) Affected |
— | — |
| SECONDARY Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4 |
6; 2; 12; 2 | — |
| SECONDARY Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4 |
8; 9; 19; 17 | — |
| SECONDARY Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4 |
0; 0; 6; 1 | — |
| SECONDARY Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4 |
0; 0; 6; 4 | — |
| SECONDARY Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4 |
0; 0; 12; 2 | — |
| SECONDARY Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4 |
0; 0; 7; 1 | — |
| SECONDARY Mean Percent Change From Baseline to Week 4 in Pruritus (Target Lesion) |
-6.8; -40.2 | — |
| SECONDARY Mean Percent Change From Baseline to Week 4 in Percent (%) of Body Surface Area (BSA) Affected |
— | — |
Eligibility Criteria
Inclusion Criteria
- Outpatient, male or female of any race, and at least 12 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.
- Mild to moderate, plaque-type psoriasis
- Target lesion on the trunk or extremities (excluding palms/soles, elbows, or knees) with a score of 2 or 3 for each of erythema, scaling and plaque thickness
- Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization Forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian.
Exclusion Criteria
- Female subjects who are pregnant (positive urine pregnancy test) breast feeding or who are of childbearing potential and not practicing a reliable method of birth control
- Known allergy to clobetasol propionate or other topical corticosteroids; or to any component of the investigational formulations
- Subjects who have not complied with the proper wash-out periods for prohibited medications
- Medical condition that in the opinion of the investigator, contraindicates the subject's participation in the clinical study
- Skin disease/disorder that might interfere with the study related diagnosis or evaluations
- Evidence of recent alcohol or drug abuse
- History of poor cooperation, non-compliance with medical treatment or unreliability
Data sourced from ClinicalTrials.gov (NCT00842153). 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. Informational only — not medical advice.