Trial Outcomes & Findings for Study to Evaluate Product Duration of Use Experience With Alclometasone Dipropionate Cream (NCT NCT02075632)

NCT ID: NCT02075632

Last Updated: 2014-09-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 310 participants
• Primary outcome timeframe: Day1-Day 14
• Results posted on: 2014-09-05

Participant Flow

Participants were recruited at the clinical site

Participants with itchy skin conditions, who would use OTC treatments for relief

Participant milestones

Measure	Chronic Condition Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.	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.
Overall Study STARTED	162	148
Overall Study COMPLETED	161	143
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Measure	Chronic Condition Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.	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.
Overall Study Adverse Event	1	1
Overall Study Lost to Follow-up	0	3
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Chronic Condition n=162 Participants Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.	Occasional Itch n=148 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	Total n=310 Participants Total of all reporting groups
Age, Continuous	47.5 Years STANDARD_DEVIATION 15.68 • n=5 Participants	50.6 Years STANDARD_DEVIATION 14.10 • n=7 Participants	49 Years STANDARD_DEVIATION 15.0 • n=5 Participants
Sex: Female, Male Female	105 Participants n=5 Participants	112 Participants n=7 Participants	217 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	36 Participants n=7 Participants	93 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Chronic Condition n=161 Participants Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.	Occasional Itch n=143 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.
Number of Participants With Incorrect Duration of Use of the Medication	97 Participants	89 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Chronic Condition n=162 Participants Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.	Occasional Itch n=144 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.
Number of Times Per Day Participants Used the Product Average Application Per Day	1.95 Applications Standard Deviation 0.79	1.92 Applications Standard Deviation 0.65
Number of Times Per Day Participants Used the Product Maximum Application Per Day	2.6 Applications Standard Deviation 1.26	2.7 Applications Standard Deviation 1.05

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Chronic Condition n=162 Participants Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.	Occasional Itch n=144 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.
Number of Days of Use	12.5 Days Standard Deviation 2.70	11.8 Days Standard Deviation 3.35

Adverse Events

Chronic Condition

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Occasional Itch

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Chronic Condition n=162 participants at risk Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.	Occasional Itch n=144 participants at risk 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm	0.62% 1/162 • Number of events 1 • 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.	0.00% 0/144 • 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.

Other adverse events

Measure	Chronic Condition n=162 participants at risk Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.	Occasional Itch n=144 participants at risk 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.
Infections and infestations Sinusitis	1.2% 2/162 • Number of events 2 • 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.	0.69% 1/144 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders Erythema	1.2% 2/162 • Number of events 2 • 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.	1.4% 2/144 • Number of events 2 • 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.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER