Study to Evaluate Product Duration of Use Experience With Alclometasone Dipropionate Cream

A Mult-Center, Open-Label Study to Evaluate Product Duration of Use Experience With Aclometasone Diproprionate Cream

This is a multi-center, open-label study to evaluate whether participants follow the duration of use instructions for short-term use of alclometasone dipropionate in a population of participants with itchy skin conditions who would use OTC treatments for relief. The study population will be composed of two different cohorts: chronic condition sufferers (eczema or psoriasis) and participants who suffer from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.

Study Overview

• Status: Completed
• Conditions: Psoriasis; Eczema; Itch; Allergy Symptoms
• Intervention / Treatment: Drug: Alclometasone dipropionate cream

Detailed Description

Approximately 313 participants who are currently suffering from an itchy skin condition caused by eczema or psoriasis or any occasional itchy skin experiences will be enrolled into the study to get 250 participants who complete the study (at least 100 to each of the cohorts). After evaluation of the study criteria, the site staff will dispense product and a diary card to the subject to use over the next 14 days. At the end of the 14 days, each participant will come to the research site to return the remaining product and undergo the study termination interview with the Concentrics nurse via telephone. The study will be conducted in approximately 15 research sites located throughout the United States (US).

• Study Type: Interventional
• Enrollment (Actual): 310
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 63 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: At least 12 years of age.

• Condition: Currently experiencing itch associated with one of the following skin conditions:

  • psoriasis or eczema,
  • minor skin conditions such as those caused by poison ivy, oak, or sumac, insect bites, or use of cosmetics, soaps, detergents, or jewelry.
• Compliance: Subject or subject's parent or legal guardian understands and is willing, able and likely to comply with all study procedures and restrictions.
• Consent: Subject or subject's parent or legal guardian demonstrates ability to read and understand English and is willing to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form (and assent as appropriate).

Exclusion Criteria:

• Pregnancy: Women who are known to be pregnant (as self-reported) or who are intending to become pregnant over the duration of the study. Women of childbearing potential will be allowed to participate in the study so long as they are practicing a reliable method of contraception (e.g. hormonal birth control such as pill, patch, implant or injection; intrauterine device, double barrier methods, tubal ligation, vasectomized spouse or abstinence).
• Corticosteroid Use: Subject has used a corticosteroid treatment within two weeks of the screening visit at the start of the study.
• Breast-feeding: Women who are breastfeeding.
• Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to alclometasone cream (or closely related compounds), or any of their stated ingredients.
• Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alclometasone dipropionate cream; Alclometasone dipropionate cream 0.05% will be applied by the participants topically on the affected areas per label instructions for 14 days.	Drug: Alclometasone dipropionate cream; Alclometasone dipropionate cream 0.05% (15 g)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Incorrect Duration of Use of the Medication	Incorrect duration of use was defined as the use of study medication for more than 7 consecutive days and/or more than three times in a day. Participants were asked the reasons of doing so and they were allowed to select multiple reasons also, if applicable.	Day1-Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Times Per Day Participants Used the Product	The number of study medication applications, was summarized for all subjects and by cohort in evaluable subjects.	Day1-Day14
Number of Days of Use	The number of days subjects used the study medication was summarized for all subjects and by cohort in evaluable subjects.	Day 1-Day 14

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): November 1, 2006
• Study Completion (Actual): November 1, 2006

Study Registration Dates

• First Submitted: January 28, 2014
• First Submitted That Met QC Criteria: February 27, 2014
• First Posted (Estimate): March 3, 2014

Study Record Updates

• Last Update Posted (Estimate): September 5, 2014
• Last Update Submitted That Met QC Criteria: August 28, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Psoriasis; Itch; Eczema; Alclometasone dipropionate
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Dermatitis; Skin Diseases, Eczematous; Psoriasis; Eczema; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Alclometasone dipropionate
• Other Study ID Numbers: P2200440