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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alclometasone dipropionate cream | Drug | Alclometasone dipropionate cream 0.05% (15 g) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Days of Use |
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Inclusion Criteria:
Age: At least 12 years of age.
Condition: Currently experiencing itch associated with one of the following skin conditions:
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:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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Participants with itchy skin conditions, who would use OTC treatments for relief
Participants were recruited at the clinical site
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| ID | Title | Description |
|---|---|---|
| FG000 | Chronic Condition | Participants who suffered from eczema or psoriasis where an anti-itch medication would be used. |
| FG001 | Occasional Itch | Participants who suffered 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chronic Condition | Participants who suffered from eczema or psoriasis where an anti-itch medication would be used. |
| BG001 | Occasional Itch | Participants who suffered 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | A participant was evaluable for analysis of the rate of incorrect use if he or she used the study medication at least once and provided use information at least 8 days after the enrollment visit. | Posted | Number | Participants | Day1-Day 14 |
|
Adverse events were collected up to 48 hours after visit 2(14 days)
The safety population included all subjects who used the study medication at least once and completed the Visit 2 study procedures, regardless of the time elapsed from enrollment to that visit. Out of 148 participants, 144 participants qualified for safety population in the occasional itch arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chronic Condition | Participants who suffered from eczema or psoriasis where an anti-itch medication would be used. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malignant Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D004485 | Eczema |
| D011565 | Psoriasis |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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The number of days subjects used the study medication was summarized for all subjects and by cohort in evaluable subjects.
| Day 1-Day 14 |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants who suffered 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. |
|
|
| 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. | A subject was evaluable for average number of applications per day and maximum number of applications per day if he or she used the study medication at least once and provided use information at Visit 2. Data for four subjects was not available for this analysis. | Posted | Mean | Standard Deviation | Applications | Day1-Day14 |
|
|
|
| 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. | A subject was evaluable for summaries of number of days of use, if he or she used the study medication at least once and provided use information at Visit 2. Data for 4 subjects was not available for this analysis. | Posted | Mean | Standard Deviation | Days | Day 1-Day 14 |
|
|
|
| 1 |
| 162 |
| 4 |
| 162 |
| EG001 | Occasional Itch | Participants who suffered 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. | 0 | 144 | 3 | 144 |
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D017444 |
| Skin Diseases, Papulosquamous |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |