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

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ClinicalTrials.gov Identifier: NCT02075632
Recruitment Status : Completed
First Posted : March 3, 2014
Results First Posted : July 14, 2014
Last Update Posted : September 5, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Eczema Allergy Symptoms Psoriasis Itch Drug: Alclometasone dipropionate cream Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Mult-Center, Open-Label Study to Evaluate Product Duration of Use Experience With Aclometasone Diproprionate Cream
Study Start Date : September 2006
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

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Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Incorrect Duration of Use of the Medication [ Time Frame: Day1-Day 14 ]
    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.


Secondary Outcome Measures :
  1. Number of Times Per Day Participants Used the Product [ Time Frame: Day1-Day14 ]
    The number of study medication applications, was summarized for all subjects and by cohort in evaluable subjects.

  2. Number of Days of Use [ Time Frame: Day 1-Day 14 ]
    The number of days subjects used the study medication was summarized for all subjects and by cohort in evaluable subjects.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02075632


Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02075632    
Other Study ID Numbers: P2200440
First Posted: March 3, 2014    Key Record Dates
Results First Posted: July 14, 2014
Last Update Posted: September 5, 2014
Last Verified: August 2014
Keywords provided by GlaxoSmithKline:
Alclometasone dipropionate
Eczema
Psoriasis
Itch
Additional relevant MeSH terms:
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Psoriasis
Eczema
Skin Diseases, Papulosquamous
Skin Diseases
Dermatitis
Skin Diseases, Eczematous
 Alclometasone dipropionate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs