Allergy Symptoms, Eczema, Itch, Psoriasis
Conditions
Keywords
Alclometasone dipropionate, Eczema, Psoriasis, Itch
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).
Interventions
DRUGAlclometasone dipropionate cream
Alclometasone dipropionate cream 0.05% (15 g)
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Incorrect Duration of Use of the Medication | Day1-Day 14 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Times Per Day Participants Used the Product | Day1-Day14 | The number of study medication applications, was summarized for all subjects and by cohort in evaluable subjects. |
| Number of Days of Use | Day 1-Day 14 | The number of days subjects used the study medication was summarized for all subjects and by cohort in evaluable subjects. |
Participant flow
Recruitment details
Participants were recruited at the clinical site
Pre-assignment details
Participants with itchy skin conditions, who would use OTC treatments for relief
Participants by arm
| Arm | Count |
|---|---|
| Chronic Condition Participants who suffered from eczema or psoriasis where an anti-itch medication would be used. | 162 |
| 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 | 148 |
| Total | 310 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Chronic Condition | Occasional Itch | Total |
|---|---|---|---|
| Age, Continuous | 47.5 Years STANDARD_DEVIATION 15.68 | 50.6 Years STANDARD_DEVIATION 14.1 | 49 Years STANDARD_DEVIATION 15 |
| Sex: Female, Male Female | 105 Participants | 112 Participants | 217 Participants |
| Sex: Female, Male Male | 57 Participants | 36 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 162 | 3 / 144 |
| serious Total, serious adverse events | 1 / 162 | 0 / 144 |
Outcome results
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.
Time frame: Day1-Day 14
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chronic Condition | Number of Participants With Incorrect Duration of Use of the Medication | 97 Participants |
| Occasional Itch | Number of Participants With Incorrect Duration of Use of the Medication | 89 Participants |
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.
Time frame: Day 1-Day 14
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chronic Condition | Number of Days of Use | 12.5 Days | Standard Deviation 2.7 |
| Occasional Itch | Number of Days of Use | 11.8 Days | Standard Deviation 3.35 |
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.
Time frame: Day1-Day14
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Condition | Number of Times Per Day Participants Used the Product | Average Application Per Day | 1.95 Applications | Standard Deviation 0.79 |
| Chronic Condition | Number of Times Per Day Participants Used the Product | Maximum Application Per Day | 2.6 Applications | Standard Deviation 1.26 |
| Occasional Itch | Number of Times Per Day Participants Used the Product | Average Application Per Day | 1.92 Applications | Standard Deviation 0.65 |
| Occasional Itch | Number of Times Per Day Participants Used the Product | Maximum Application Per Day | 2.7 Applications | Standard Deviation 1.05 |