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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Eczema, Allergy Symptoms, Psoriasis, Itch

Intervention / Treatment
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* Drug: Alclometasone dipropionate cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alclometasone dipropionate cream<br>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<br>* Alclometasone dipropionate cream 0.05% (15 g)<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Itch, Alclometasone dipropionate, Psoriasis, Eczema