Trial Outcomes & Findings for A NOVel Moisturiser for Atopic Dermatitis: Effect on the Skin Barrier (NCT NCT03901144)

Last Updated: 2021-12-20

Results Overview

The change in TEWL from treated and untreated skin before and after induction of skin irritation with SLS. SLS increases TEWL. An effective treatment protects skin from irritation and less TEWL increase is anticipated compared to untreated skin

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

day 29 prior to irritant application and day 31 following application

Results posted on

2021-12-20

Participant Flow

Medications prohibited to use \>28 Days, 28 Days, 14 Days and 7 Days, respectively, Prior to Baseline/Day 1 and throughout the study are listed in the Clinical Trial Protocol Use of bland (non-medicated) emollients, moisturisers or sunscreen on the test areas, within 7 days prior to Visit 1 was also prohibited Use of bland (non-medicated) emollient(s) was permitted during the study to manage dry skin in areas surrounding but not on or overlapping the test areas.

Unit of analysis: Skin areas

Participant milestones

Participant milestones
Measure	Test Cream (2% Urea/20% Glycerol) All participants used 3 creams on their lower volar forearms and one area was left untreated. I Finger Tip Unit of each cream was applied every morning and evening for 28 days	Reference Cream 1: Miniderm® 20% Cream (20% Glycerol) All participants used 3 creams on their lower volar forearms and one area was left untreated. I Finger Tip Unit of each cream was applied every morning and evening for 28 days	Reference Cream 2: Diprobase® Cream (Cream Without Humectants) All participants used 3 creams on their lower volar forearms and one area was left untreated. I Finger Tip Unit of each cream was applied every morning and evening for 28 days	Untreated All participants used 3 creams on their lower volar forearms and one area was left untreated. No cream was applied on this area
Overall Study STARTED	50 50	50 50	50 50	50 50
Overall Study COMPLETED	49 49	49 49	49 49	49 49
Overall Study NOT COMPLETED	1 1	1 1	1 1	1 1

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Cream (2% Urea/20% Glycerol) All participants used 3 creams on their lower volar forearms and one area was left untreated. I Finger Tip Unit of each cream was applied every morning and evening for 28 days	Reference Cream 1: Miniderm® 20% Cream (20% Glycerol) All participants used 3 creams on their lower volar forearms and one area was left untreated. I Finger Tip Unit of each cream was applied every morning and evening for 28 days	Reference Cream 2: Diprobase® Cream (Cream Without Humectants) All participants used 3 creams on their lower volar forearms and one area was left untreated. I Finger Tip Unit of each cream was applied every morning and evening for 28 days	Untreated All participants used 3 creams on their lower volar forearms and one area was left untreated. No cream was applied on this area
Overall Study Lost to Follow-up	1	1	1	1

Baseline Characteristics

A NOVel Moisturiser for Atopic Dermatitis: Effect on the Skin Barrier

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subject Using 3 Creams n=49 Participants Each subject used three creams on their volar forearms and had one skin area untreated 4 treated skin areas: Test cream Glycerol cream Cream without humectants Untreated
Age, Continuous	37.6 years STANDARD_DEVIATION 16.26 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom	49 participants n=5 Participants

PRIMARY outcome

Timeframe: day 29 prior to irritant application and day 31 following application

Population: Each participant used three creams on their volar forearms and one skin area was left untreated. A skin irritant was applied on each treatment area (n=4) after end of cream treatment period. The irritant was left on the skin for 24h and the Trans Epidermal Water Loss (TEWL) was measured after another 24h and compared to TEWL measured after treatment but before application of irritant

Outcome measures

Outcome measures
Measure	Test Cream (2% Urea/20% Glycerol) n=49 skin areas on volar forearms Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days Test cream: Moisturizing cream for topical application	Reference Cream 1: Miniderm® 20% Cream (20% Glycerol) n=49 skin areas on volar forearms Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days Glycerol cream: Moisturizing cream for topical application	Reference Cream 2: Diprobase® Cream (Cream Without Humectants) n=49 skin areas on volar forearms Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days Cream without humectants: Emollient cream for topical application	Untreated n=49 skin areas on volar forearms Untreated are on the volar forearm
Skin Barrier Strengthening Effect by Measurement of Trans Epidermal Water Loss (TEWL) Before and After Induction of Skin Irritation	19.790 TEWL (g/m^2·h) change from day 29 to 31 Standard Deviation 13.860	24.680 TEWL (g/m^2·h) change from day 29 to 31 Standard Deviation 14.693	29.648 TEWL (g/m^2·h) change from day 29 to 31 Standard Deviation 14.299	28.646 TEWL (g/m^2·h) change from day 29 to 31 Standard Deviation 13.668

PRIMARY outcome

Timeframe: The 2D Skin Imaging was performed on day 15, day 29 and on day 31. Only day 29 and 31 was included in the statistical analysis

Population: In some participants it was not possible to analyze all images, therefore the Overall Number of Participants Analyzed in this outcome measure differs compared to the total number of participants included in the study

Skin redness measurement by Objective Erythema (2D Skin Imaging) on treated and untreated skin before (day 29) and after (day 31) induction of skin irritation with SLS. Captured 2D images are analysed to determine the skin erythema index (degree of redness, arbitrary numerical value), where a higher value denotes a stronger reaction/more redness. An effective treatment is anticipated to protect the skin from irritation, i.e. a weaker reaction from SLS/less redness compared to the untreated skin. Data is presented as change from day 29 to day 31

Outcome measures

Outcome measures
Measure	Test Cream (2% Urea/20% Glycerol) n=46 skin areas on volar forearms Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days Test cream: Moisturizing cream for topical application	Reference Cream 1: Miniderm® 20% Cream (20% Glycerol) n=46 skin areas on volar forearms Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days Glycerol cream: Moisturizing cream for topical application	Reference Cream 2: Diprobase® Cream (Cream Without Humectants) n=45 skin areas on volar forearms Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days Cream without humectants: Emollient cream for topical application	Untreated n=46 skin areas on volar forearms Untreated are on the volar forearm
Skin Barrier Strengthening Effect by Measurement of Skin Redness Before and After Induction of Skin Irritation as Assessed by the Erythema Index (Change From Day 29 to Day 31)	13.261 Arbitrary Units Standard Deviation 6.9086	14.833 Arbitrary Units Standard Deviation 6.0440	17.981 Arbitrary Units Standard Deviation 7.3550	16.747 Arbitrary Units Standard Deviation 6.7629

PRIMARY outcome

Timeframe: Measured on day 29 and 31

Objective skin redness measurement by Mexameter on treated and untreated skin before (day 29) and after (day 31) induction of skin irritation with SLS. Skin redness is measured using a C\&K Mexameter probe to quantify SLS-induced skin irritation (arbitrary numerical scale). An effective treatment is anticipated to protect the skin from irritation, i.e. a weaker reaction from SLS/less redness compared to the untreated skin. Data is presented as change from day 29 to day 31

Outcome measures

Outcome measures
Measure	Test Cream (2% Urea/20% Glycerol) n=48 skin areas on volar forearms Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days Test cream: Moisturizing cream for topical application	Reference Cream 1: Miniderm® 20% Cream (20% Glycerol) n=48 skin areas on volar forearms Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days Glycerol cream: Moisturizing cream for topical application	Reference Cream 2: Diprobase® Cream (Cream Without Humectants) n=47 skin areas on volar forearms Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days Cream without humectants: Emollient cream for topical application	Untreated n=48 skin areas on volar forearms Untreated are on the volar forearm
Skin Barrier Strengthening Effect by Measurement of Skin Redness Before and After Induction of Skin Irritation as Assessed by Mexameter (Change From Day 29 to Day 31)	80.859 Arbitrary Units Standard Deviation 53.901	82.893 Arbitrary Units Standard Deviation 53.150	106.39 Arbitrary Units Standard Deviation 56.315	98.951 Arbitrary Units Standard Deviation 53.917

PRIMARY outcome

Timeframe: Skin redness was scored on day 29

Skin redness by visual scoring on treated and untreated skin before induction of skin irritation with SLS. Skin redness was evaluated on a 4-point visual scale from 0 to 3, where 0 indicates no redness/reaction and 3 indicates strong erythema.

Outcome measures

Outcome measures
Measure	Test Cream (2% Urea/20% Glycerol) n=49 skin areas on volar forearms Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days Test cream: Moisturizing cream for topical application	Reference Cream 1: Miniderm® 20% Cream (20% Glycerol) n=49 skin areas on volar forearms Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days Glycerol cream: Moisturizing cream for topical application	Reference Cream 2: Diprobase® Cream (Cream Without Humectants) n=49 skin areas on volar forearms Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days Cream without humectants: Emollient cream for topical application	Untreated n=49 skin areas on volar forearms Untreated are on the volar forearm
Skin Barrier Strengthening Effect by Measurement of Skin Redness Before Induction of Skin Irritation as Assessed by Visual Scoring	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: Skin redness was scored on day 31

Skin redness by visual scoring on treated and untreated skin after induction of skin irritation with SLS. Skin redness was evaluated on a 4-point visual scale from 0 to 3, where 0 indicates no redness/reaction and 3 indicates strong erythema.

Outcome measures

Outcome measures
Measure	Test Cream (2% Urea/20% Glycerol) n=49 skin areas on volar forearms Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days Test cream: Moisturizing cream for topical application	Reference Cream 1: Miniderm® 20% Cream (20% Glycerol) n=49 skin areas on volar forearms Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days Glycerol cream: Moisturizing cream for topical application	Reference Cream 2: Diprobase® Cream (Cream Without Humectants) n=49 skin areas on volar forearms Topical cream, 1 Finger Tip Unit per treatment area on the lower volar forearms twice daily for 28 days Cream without humectants: Emollient cream for topical application	Untreated n=49 skin areas on volar forearms Untreated are on the volar forearm
Skin Barrier Strengthening Effect by Measurement of Skin Redness After Induction of Skin Irritation as Assessed by Visual Scoring	0.99 units on a scale Standard Deviation 0.691	1.08 units on a scale Standard Deviation 0.649	1.45 units on a scale Standard Deviation 0.718	1.35 units on a scale Standard Deviation 0.680

Adverse Events

Test Cream (2% Urea/20% Glycerol)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Reference Cream 1: Miniderm® 20% Cream (20% Glycerol)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Reference Cream 2: Diprobase® Cream (Cream Without Humectants)

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Untreated

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Test Cream (2% Urea/20% Glycerol) n=49 participants at risk 1 Finger Tip Unit of cream was applied to 1 of 4 skin areas on the lower volar forearm of the participant every morning and evening for 28 days	Reference Cream 1: Miniderm® 20% Cream (20% Glycerol) n=49 participants at risk 1 Finger Tip Unit of cream was applied to 1 of 4 skin areas on the lower volar forearm of the participant every morning and evening for 28 days	Reference Cream 2: Diprobase® Cream (Cream Without Humectants) n=49 participants at risk 1 Finger Tip Unit of cream was applied to 1 of 4 skin areas on the lower volar forearm of the participant every morning and evening for 28 days	Untreated n=49 participants at risk 1 of 4 skin areas on the lower volar forearm of the participant was left untreated
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	2.0% 1/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.
Skin and subcutaneous tissue disorders Eczema	2.0% 1/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	4.1% 2/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	2.0% 1/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	2.0% 1/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.
General disorders Application site bruise	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	4.1% 2/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.
General disorders Application site eczema	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	2.0% 1/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.
General disorders Application site erythema	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	2.0% 1/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	6.1% 3/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.
General disorders Application site papules	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	4.1% 2/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.
General disorders Application site pruritus	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	4.1% 2/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.
General disorders Application site rash	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	6.1% 3/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.
General disorders Application site reaction	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	2.0% 1/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.
General disorders Application site urticaria	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	2.0% 1/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.	0.00% 0/49 • Adverse events were recorded throughout duration of the study, i.e. from day 1 to day 31 Treatment emergent AEs were defined to be those starting on or after visit 1 treatment dispensing, or those without an onset date.

Additional Information

Dr Tina Holm

Perrigo/ACO Hud Nordic

Phone: +46732744113

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Clause 10 of the Clinical Trial Agreement: The Sponsor agrees that the Principal Investigator shall be permitted to present at symposia, national and regional professional meetings and to publish in journals, theses or dissertations, or otherwise of their own choosing, the methods and Results of the Clinical Trial, subject to this Clause 10 and any publication policy described in the Protocol, provided any such policy is consistent with the Joint Position.
Publication restrictions are in place

Restriction type: OTHER