Ignite Creation Date:
2024-05-05 @ 10:52 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01202149
Status:
COMPLETED
Last Update Posted:
2011-04-15
First Post:
2010-09-14
Brief Title:
Bilateral Comparison Study of Elidel 1 and Hylatopic Plus Emollient Foam for the Treatment of Subjects With Atopic Dermatitis
Sponsor:
Frankel Amylynne MD
Organization:
Frankel Amylynne MD
Study Overview
Official Title:
Bilateral Comparison Study of Elidel Pimecrolimus Cream 1 and Hylatopic Plus Emollient Foam Emollient Foam in the Treatment of Subjects With Atopic Dermatitis
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an investigator-blinded bilateral comparison study in 30 subjects with atopic dermatitis It is designed to assess and compare the efficacy of Elidel pimecrolimus cream 1 and Hylatopic Plus Emollient Foam in subjects with atopic dermatitis Subjects will apply Elidel pimecrolimus cream 1 twice daily for four weeks on a chosen target eczematous area located on one side of the body and then apply Hylatopic Plus Emollient Foam three times daily on a symmetrical target eczematous area on the opposite side of the body A randomized list will be created to determine which side the subject applies each medication
Subjects will be consented prior to any study evaluations or procedures After signing the consent and meeting all inclusionexclusion criteria qualified and enrolled subjects will apply study medication Elidel and Hylatopic Plus Emollient Foam to chosen affected areas for four weeks Photography will be used to record the location of target lesions at the baseline week two and week fourfinal visits Subjects disease status will be assessed by two methods 1 Physicians Global Assessment PGA and 2 Target Lesion Symptom Score TLSS see sections VB2 and VB3 PGA as well as TLSS will be made at baseline Day 0 week two Day 14 - 2 days and week 4final visit Day 28 - 2days visits for each of the target lesions Half scales ie 05 15 will not be used The presence or absence of skin atrophy and telangiectasias will be noted at each study visit as well
Additionally subjects self-assessments of their perception of degree of disease and itching severity control will be collected at each visit for each target lesion This assessment will be made using a four point scale and Itch Severity Scale visual analogue score respectively see section VB4 Lastly subjects will take a Product Preference Survey at week 4final visit Day 28 - 2days Parents or guardians will moderate Product Preference Surveys for subjects that are younger than 12 years of age
Subjects will be consented prior to any study evaluations or procedures After signing the consent and meeting all inclusionexclusion criteria qualified and enrolled subjects will apply study medication Elidel and Hylatopic Plus Emollient Foam to chosen affected areas for four weeks Photography will be used to record the location of target lesions at the baseline week two and week fourfinal visits Subjects disease status will be assessed by two methods 1 Physicians Global Assessment PGA and 2 Target Lesion Symptom Score TLSS see sections VB2 and VB3 PGA as well as TLSS will be made at baseline Day 0 week two Day 14 - 2 days and week 4final visit Day 28 - 2days visits for each of the target lesions Half scales ie 05 15 will not be used The presence or absence of skin atrophy and telangiectasias will be noted at each study visit as well
Additionally subjects self-assessments of their perception of degree of disease and itching severity control will be collected at each visit for each target lesion This assessment will be made using a four point scale and Itch Severity Scale visual analogue score respectively see section VB4 Lastly subjects will take a Product Preference Survey at week 4final visit Day 28 - 2days Parents or guardians will moderate Product Preference Surveys for subjects that are younger than 12 years of age
Detailed Description:
This is an investigator-blinded bilateral comparison study in 30 subjects with atopic dermatitis It is designed to assess and compare the efficacy of Elidel pimecrolimus cream 1 and Hylatopic Plus Emollient Foam in subjects with atopic dermatitis Subjects will apply Elidel pimecrolimus cream 1 twice daily for four weeks on a chosen target eczematous area located on one side of the body and then apply Hylatopic Plus Emollient Foam three times daily on a symmetrical target eczematous area on the opposite side of the body A randomized list will be created to determine which side the subject applies each medication
Subjects will be consented prior to any study evaluations or procedures After signing the consent and meeting all inclusionexclusion criteria qualified and enrolled subjects will apply study medication Elidel and Hylatopic Plus Emollient Foam to chosen affected areas for four weeks Photography will be used to record the location of target lesions at the baseline week two and week fourfinal visits Subjects disease status will be assessed by two methods 1 Physicians Global Assessment PGA and 2 Target Lesion Symptom Score TLSS see sections VB2 and VB3 PGA as well as TLSS will be made at baseline Day 0 week two Day 14 - 2 days and week 4final visit Day 28 - 2days visits for each of the target lesions Half scales ie 05 15 will not be used The presence or absence of skin atrophy and telangiectasias will be noted at each study visit as well
Additionally subjects self-assessments of their perception of degree of disease and itching severity control will be collected at each visit for each target lesion This assessment will be made using a four point scale and Itch Severity Scale visual analogue score respectively see section VB4 Lastly subjects will take a Product Preference Survey at week 4final visit Day 28 - 2days Parents or guardians will moderate Product Preference Surveys for subjects that are younger than 12 years of age
Subjects will be consented prior to any study evaluations or procedures After signing the consent and meeting all inclusionexclusion criteria qualified and enrolled subjects will apply study medication Elidel and Hylatopic Plus Emollient Foam to chosen affected areas for four weeks Photography will be used to record the location of target lesions at the baseline week two and week fourfinal visits Subjects disease status will be assessed by two methods 1 Physicians Global Assessment PGA and 2 Target Lesion Symptom Score TLSS see sections VB2 and VB3 PGA as well as TLSS will be made at baseline Day 0 week two Day 14 - 2 days and week 4final visit Day 28 - 2days visits for each of the target lesions Half scales ie 05 15 will not be used The presence or absence of skin atrophy and telangiectasias will be noted at each study visit as well
Additionally subjects self-assessments of their perception of degree of disease and itching severity control will be collected at each visit for each target lesion This assessment will be made using a four point scale and Itch Severity Scale visual analogue score respectively see section VB4 Lastly subjects will take a Product Preference Survey at week 4final visit Day 28 - 2days Parents or guardians will moderate Product Preference Surveys for subjects that are younger than 12 years of age
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None