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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02075632
• Other study ID #: P2200440
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2014
• Last updated: August 28, 2014
• Start date: September 2006
• Est. completion date: November 2006

Study information

• Verified date: August 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergy Symptoms
• Eczema
• Itch
• Psoriasis

Intervention

Drug:
• Alclometasone dipropionate cream
Alclometasone dipropionate cream 0.05% (15 g)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No