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

NCT02075632 | Completed Phase 2 Results

• 1 other identifier: P2200440
• Study Type: interventional
• Target: 310
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Eczema; Allergy Symptoms; Psoriasis; Itch

Keywords

Alclometasone dipropionate; Eczema; Psoriasis; Itch

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Times Per Day Participants Used the Product

  Day1-Day14

• Number of Days of Use

  Day 1-Day 14

Study Arms (1)

Alclometasone dipropionate cream

EXPERIMENTAL

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

Interventions

Alclometasone dipropionate cream DRUG

Alclometasone dipropionate cream 0.05% (15 g)

Alclometasone dipropionate cream

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Eczema; Psoriasis; Pruritus

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: March 3, 2014
• Study Start: September 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: September 5, 2014
• Results First Posted: July 14, 2014

Record last verified: 2014-08