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OpenTrials
Completed

NCT Number: NCT01893567

Subject Reported Target-lesion Numeric Rating Scale Evaluation by Subjects With Plaque Psoriasis Treated With Clobex® (Clobetasol Propionate) Spray 0.05%

The aim of this study is to investigate the utility of a technological based rating scale for assessing improvement in plaque psoriasis with Clobex spray treatment.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects 18 years of age or older.
  • Subjects with a board certified dermatologist clinical diagnosis of active moderate to severe psoriasis lesions affecting up to 20% of the body surface area at the baseline visit, and in the opinion of the investigator, is otherwise a good candidate for treatment with clobetasol propionate 0.05% spray.
  • Subjects with a target lesion of at least 1 cm x 1 cm
  • Subjects who agree to be photographed at each visit

Exclusion criteria

  • Subjects with any condition or presentation that may, in the opinion of the investigator, may put the subject at risk, may confound study results, or may interfere with participation in the study.
  • Subjects with any known allergies to any of the ingredients listed on the test article label or surgical ink.
  • Subjects who are pregnant or breast-feeding, or who plan to become pregnant or breast feed during the course of the trial.
  • Subjects that are relatives of the investigator, or are themselves or a relative of any study staff or any Galderma employee.
  • Subjects who have participated in an investigational study within 30 days of enrollment; participated in biologic investigational studies within 90 days of enrollment, or subjects planning to participate in any other interventional clinical research study while enrolled in this trial.

Treatment and study plan

Clobex Spray

Drug

Other names: Clobetasol propionate spray

Primary outcomes

  1. Subject Reported Target Lesion Severity Score.

    Time frame: 2 weeks

    Subject reported mean scores of the target lesion numeric rating scale (TL-NRS; scale of 0 (no psoriasis) to 10 (very severe psoriasis)) at end of study.

Secondary outcomes

  1. Investigator Reported Target Lesion Severity Score

    Time frame: 2 weeks

    Investigator reported mean scores of the target lesion numeric rating scale (TL-NRS; scale of 0 (no psoriasis) to 10 (very severe psoriasis)) at end of study

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 9, 2013
Registry last updated
Sep 27, 2022

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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