Trial · NCT03901144
A NOVel Moisturiser for Atopic Dermatitis: Effect on the Skin Barrier
NCT03901144, Phase 2, Completed, ACO Hud Nordic AB; results first posted 2021-12-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A NOVel Moisturiser for Atopic Dermatitis: Effect on the Skin Barrier. Trials, record NCT03901144. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03901144
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A NOVel Moisturiser for Atopic Dermatitis: Effect on the Skin Barrier
- NCT number
- NCT03901144
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- ACO Hud Nordic AB
- Conditions
- Dermatitis, Atopic
- Interventions
- 2% urea/20% glycerol cream, Miniderm® 20% cream, Diprobase® cream
- First posted
- 2019-04-03
- Last updated
- 2021-12-20
- Other registries' IDs
- eudract:2018-002945-12
- Results first posted
- 2021-12-20
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Skin Barrier Strengthening Effect by Measurement of Trans Epidermal Water Loss (TEWL) Before and After Induction of Skin Irritation | day 29 prior to irritant application and day 31 following application | 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 |
| Primary | 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) | 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 | 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 |
| Primary | 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) | 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 |
| Primary | Skin Barrier Strengthening Effect by Measurement of Skin Redness Before Induction of Skin Irritation as Assessed by Visual Scoring | 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. |
| Primary | Skin Barrier Strengthening Effect by Measurement of Skin Redness After Induction of Skin Irritation as Assessed by Visual Scoring | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Skin Barrier Strengthening Effect by Measurement of Trans Epidermal Water Loss (TEWL) Before and After Induction of Skin Irritation | day 29 prior to irritant application and day 31 following application | 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 | TEWL (g/m^2·h) change from day 29 to 31 | MEAN |
| PRIMARY | 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) | 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 | 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 | Arbitrary Units | MEAN |
| PRIMARY | 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) | Measured on day 29 and 31 | 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 | Arbitrary Units | MEAN |
| PRIMARY | Skin Barrier Strengthening Effect by Measurement of Skin Redness Before Induction of Skin Irritation as Assessed by Visual Scoring | Skin redness was scored on day 29 | units on a scale | MEAN | |
| PRIMARY | Skin Barrier Strengthening Effect by Measurement of Skin Redness After Induction of Skin Irritation as Assessed by Visual Scoring | Skin redness was scored on day 31 | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Skin Barrier Strengthening Effect by Measurement of Trans Epidermal Water Loss (TEWL) Before and After Induction of Skin Irritation | Test Cream (2% Urea/20% Glycerol) | 19.790 | Standard Deviation 13.860 | TEWL (g/m^2·h) change from day 29 to 31 | |
| Skin Barrier Strengthening Effect by Measurement of Trans Epidermal Water Loss (TEWL) Before and After Induction of Skin Irritation | Reference Cream 1: Miniderm® 20% Cream (20% Glycerol) | 24.680 | Standard Deviation 14.693 | TEWL (g/m^2·h) change from day 29 to 31 | |
| Skin Barrier Strengthening Effect by Measurement of Trans Epidermal Water Loss (TEWL) Before and After Induction of Skin Irritation | Reference Cream 2: Diprobase® Cream (Cream Without Humectants) | 29.648 | Standard Deviation 14.299 | TEWL (g/m^2·h) change from day 29 to 31 | |
| Skin Barrier Strengthening Effect by Measurement of Trans Epidermal Water Loss (TEWL) Before and After Induction of Skin Irritation | Untreated | 28.646 | Standard Deviation 13.668 | TEWL (g/m^2·h) change from day 29 to 31 | |
| 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) | Test Cream (2% Urea/20% Glycerol) | 13.261 | Standard Deviation 6.9086 | Arbitrary Units | |
| 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) | Reference Cream 1: Miniderm® 20% Cream (20% Glycerol) | 14.833 | Standard Deviation 6.0440 | Arbitrary Units | |
| 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) | Reference Cream 2: Diprobase® Cream (Cream Without Humectants) | 17.981 | Standard Deviation 7.3550 | Arbitrary Units | |
| 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) | Untreated | 16.747 | Standard Deviation 6.7629 | Arbitrary Units | |
| 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) | Test Cream (2% Urea/20% Glycerol) | 80.859 | Standard Deviation 53.901 | Arbitrary Units | |
| 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) | Reference Cream 1: Miniderm® 20% Cream (20% Glycerol) | 82.893 | Standard Deviation 53.150 | Arbitrary Units |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Test Cream (2% Urea/20% Glycerol) | 50 | 50 |
| Overall Study | STARTED | Reference Cream 1: Miniderm® 20% Cream (20% Glycerol) | 50 | 50 |
| Overall Study | STARTED | Reference Cream 2: Diprobase® Cream (Cream Without Humectants) | 50 | 50 |
| Overall Study | STARTED | Untreated | 50 | 50 |
| Overall Study | COMPLETED | Test Cream (2% Urea/20% Glycerol) | 49 | 49 |
| Overall Study | COMPLETED | Reference Cream 1: Miniderm® 20% Cream (20% Glycerol) | 49 | 49 |
| Overall Study | COMPLETED | Reference Cream 2: Diprobase® Cream (Cream Without Humectants) | 49 | 49 |
| Overall Study | COMPLETED | Untreated | 49 | 49 |
| Overall Study | NOT COMPLETED | Test Cream (2% Urea/20% Glycerol) | 1 | 1 |
| Overall Study | NOT COMPLETED | Reference Cream 1: Miniderm® 20% Cream (20% Glycerol) | 1 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events44
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Test Cream (2% Urea/20% Glycerol) | 0 | 49 | |
| other | Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Reference Cream 1: Miniderm® 20% Cream (20% Glycerol) | 0 | 49 | |
| other | Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Reference Cream 2: Diprobase® Cream (Cream Without Humectants) | 1 | 49 | |
| other | Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Untreated | 0 | 49 | |
| other | Eczema | Skin and subcutaneous tissue disorders | Test Cream (2% Urea/20% Glycerol) | 1 | 49 | |
| other | Eczema | Skin and subcutaneous tissue disorders | Reference Cream 1: Miniderm® 20% Cream (20% Glycerol) | 2 | 49 | |
| other | Eczema | Skin and subcutaneous tissue disorders | Reference Cream 2: Diprobase® Cream (Cream Without Humectants) | 1 | 49 | |
| other | Eczema | Skin and subcutaneous tissue disorders | Untreated | 0 | 49 | |
| other | Rash macular | Skin and subcutaneous tissue disorders | Test Cream (2% Urea/20% Glycerol) | 0 | 49 | |
| other | Rash macular | Skin and subcutaneous tissue disorders | Reference Cream 1: Miniderm® 20% Cream (20% Glycerol) | 0 | 49 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Test Cream (2% Urea/20% Glycerol) | 0 | 49 |
| Total, all-cause mortality | Reference Cream 1: Miniderm® 20% Cream (20% Glycerol) | 0 | 49 |
| Total, all-cause mortality | Reference Cream 2: Diprobase® Cream (Cream Without Humectants) | 0 | 49 |
| Total, all-cause mortality | Untreated | 0 | 49 |
| Total, other adverse events | Test Cream (2% Urea/20% Glycerol) | 1 | 49 |
| Total, other adverse events | Reference Cream 1: Miniderm® 20% Cream (20% Glycerol) | 6 | 49 |
| Total, other adverse events | Reference Cream 2: Diprobase® Cream (Cream Without Humectants) | 15 | 49 |
| Total, other adverse events | Untreated | 0 | 49 |
| Total, serious adverse events | Test Cream (2% Urea/20% Glycerol) | 0 | 49 |
| Total, serious adverse events | Reference Cream 1: Miniderm® 20% Cream (20% Glycerol) | 0 | 49 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03901144
GET https://conductscience.org/api/trials/v1/NCT03901144/events?page=2