Last updated: 11/04/2018 10:10:17
Study to Evaluate Product Duration of Use Experience with Alclometasone Dipropionate Cream
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Mult-Center, Open-Label Study to Evaluate Product Duration of Use Experience with Aclometasone Diproprionate Cream
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with incorrect duration of use of the medication
Timeframe: Day1-Day 14
Secondary outcomes:
Number of times per day participants used the product
Timeframe: Day1-Day14
Number of days of use
Timeframe: Day 1-Day 14
Interventions:
Drug: Alclometasone dipropionate cream
Enrollment:
310
Observational study model:
Not applicable
Primary completion date:
2006-30-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Eczema, Allergy symptoms, Psoriasis
Product
Not applicable
Collaborators
Not applicable
Study date(s)
September 2006 to November 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
12 - 65 years
Accepts healthy volunteers
No
- Age: At least 12 years of age.
- Condition: Currently experiencing itch associated with one of the following skin conditions:
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- Age: At least 12 years of age.
- 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).
Condition: Currently experiencing itch associated with one of the following skin conditions:
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.
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-30-11
Actual study completion date
2006-30-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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