Back to results

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

Primary Purpose

Eczema, Allergy Symptoms, Psoriasis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Alclometasone dipropionate cream

About this trial

This is an interventional treatment trial for Eczema focused on measuring Alclometasone dipropionate, Eczema, Psoriasis, Itch

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alclometasone dipropionate cream

Arm Description

Alclometasone dipropionate cream 0.05% will be applied by the participants topically on the affected areas per label instructions for 14 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT02075632

First Posted

January 28, 2014

Last Updated

August 28, 2014

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT02075632

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

November 2006 (Actual)

Study Completion Date

November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eczema, Allergy Symptoms, Psoriasis, Itch

Keywords

Alclometasone dipropionate, Eczema, Psoriasis, Itch

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

310 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Alclometasone dipropionate cream

Arm Type

Experimental

Arm Description

Alclometasone dipropionate cream 0.05% will be applied by the participants topically on the affected areas per label instructions for 14 days.

Intervention Type

Drug

Intervention Name(s)

Alclometasone dipropionate cream

Intervention Description

Alclometasone dipropionate cream 0.05% (15 g)

Primary Outcome Measure Information:

Title

Number of Participants With Incorrect Duration of Use of the Medication

Description

Time Frame

Day1-Day 14

Secondary Outcome Measure Information:

Title

Number of Times Per Day Participants Used the Product

Description

The number of study medication applications, was summarized for all subjects and by cohort in evaluable subjects.

Time Frame

Day1-Day14

Title

Number of Days of Use

Description

The number of days subjects used the study medication was summarized for all subjects and by cohort in evaluable subjects.

Time Frame

Day 1-Day 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs