Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
55
Countries
1
Sites
1
Atopic dermatitis
To determine whether applying a new moisturiser (Propyduo®; test product) for 4 weeks is superior in terms of skin barrier strengthening, when compared with (1) no treatment and (2) a reference product (Propyless®; reference product 1) in adults with a history of atopic dermatitis.
Key facts
- Sponsor
- ACO Hud Nordic AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 7 Dec 2023 → 14 Mar 2024
- Decision date (initial)
- 2023-12-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508560-29-00
- WHO UTN
- U1111-1296-8592
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Safety, Efficacy, Therapy
To determine whether applying a new moisturiser (Propyduo®; test product) for 4 weeks is superior in terms of skin barrier strengthening, when compared with (1) no treatment and (2) a reference product (Propyless®; reference product 1) in adults with a history of atopic dermatitis.
Secondary objectives 1
- To assess the skin barrier strengthening effects of the test product compared with a reference product (Canoderm®; reference product 2) in adults with a history of atopic dermatitis. To determine whether there is a difference between the test product and (1) no treatment and (2) the two reference products in: 1. Resting skin barrier function 2. Skin redness 3. Irritant reactions 4. Skin capacitance 5. Skin pH 6. Product consumption
Conditions and MedDRA coding
Atopic dermatitis
Regulatory references
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-507818-27-00 | A randomised controlled trial of a moisturiser for treatment of dry skin in atopic dermatitis: effect on the skin barrier in adults with a history of eczema | ACO Hud Nordic AB |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Participants ≥ 18 years old
- A history of atopic dermatitis according to UK working party criteria
- Willing and able to provide informed consent
Exclusion criteria 9
- Substantial flare-up of atopic dermatitis more than minimal (not manageable with moisturiser only) during ideally within the last 6 months
- Eczema on the volar forearms
- Participants with known or suspected allergies or contraindications to any of the IPs and AxMP ingredients
- Participants unwilling to refrain from using prohibited medication including moisturisers (other than the IP, the AxMP and the standard soap for washing)
- Female participants who, according to the participant, is pregnant or breast-feeding, or plans to become pregnant during the study
- Participants judged by the investigator to be inappropriate for the trial.
- Any serious current medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results or may be contraindicated by the use of the investigational products
- Atopic dermatitis targeted systemic therapy as well as any other immunomodulatory systemic therapy over more than 8 days in past 12 months (glucocorticoids, biologicals, cyclosporines, JAK inhibitors, off-label azathioprine, mycophenolate-mofetil, alitretionin, photo therapy)
- Any treatment with TCS' or other established topical treatment for AD within the last 6 months prior screening and throughout the study. Except the two allowed corticosteroids for treatment of flare-up during the study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Comparison of IPs on Trans Epidermal Water Loss (TEWL) on visit 3 and visit 5 between: • test product vs no treatment • test product vs Propyless®
Secondary endpoints 13
- Comparison of test product vs 1) no treatment; 2) Propyless®; 3) Canoderm® for each of the following parameters:
- Comparison of TEWL on Visit 3 and Visit 5 between test product vs Canoderm®.
- 2. Comparison of TEWL on Visit 3 between test product and comparators as well as no treatment.
- Comparison of difference to baseline (Visit 2) of TEWL on Visit 3 between test product and comparators as well as no treatment.
- Comparison of TEWL on Visit 5 between test product and comparators as well as no treatment.
- Comparison of difference to Visit 3 for scoring of SLS irritant reactions on Visit 5 between test product and comparators as well as no treatment.
- Comparison of scoring of SLS irritant reactions on Visit 5 between test product and comparators as well as no treatment.
- Comparison of redness assessment based on images [Picture analysis, USR-Clip] (redness on Visit 5 minus redness on Visit 3) between test product and comparators as well as no treatment.
- Comparison of capacitance measurements on Visit 3 between test product and comparators as well as no treatment.
- Comparison of difference to baseline (Visit 2) of capacitance measurements on Visit 3 between test product and comparators as well as no treatment.
- Comparison of skin pH on Visit 3 between test product and comparators as well as no treatment.
- Comparison of difference to baseline (Visit 2) of skin pH on Visit 3 between test product and comparators as well as no treatment.
- Comparison of product consumption (in gram) over 28 days of treatment between test product and comparators.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP49603785 · ATC
- Active substance
- Glycerol
- Substance synonyms
- GLYCERINE, GLYCERIN, GLYCEROL (E 422)
- Route of administration
- TOPICAL
- Max daily dose
- 2 ml millilitre(s)
- Max total dose
- 56 ml millilitre(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- D02AE51 — CARBAMIDE, COMBINATIONS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- new moisturiser
Comparator 2
PRD533938 · Product
- Active substance
- Urea
- Pharmaceutical form
- CREAM
- Route of administration
- TOPICAL
- Max daily dose
- 2 ml millilitre(s)
- Max total dose
- 56 ml millilitre(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- D02AE01 — CARBAMIDE
- Marketing authorisation
- 13757
- MA holder
- ACO HUD NORDIC AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Propyless 200 mg/g kutan emulsion
PRD8812731 · Product
- Active substance
- Propylene Glycol
- Substance synonyms
- PROPYLENGLYCOLUM, PROPYLENEGLYCOL, PROPYLENE GLYCOL (E 1520), PROPYLENE GLYCOL (E1520), 1,2-PROPYLENE GLYCOL
- Pharmaceutical form
- CUTANEOUS EMULSION
- Route of administration
- TOPICAL
- Max daily dose
- 2 ml millilitre(s)
- Max total dose
- 56 ml millilitre(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- D02AX — OTHER EMOLLIENTS AND PROTECTIVES
- Marketing authorisation
- 15241
- MA holder
- KARO PHARMA AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 3
Aqua ad iniectabilia Braun Lösungsmittel zur Herstellung von Parenteralia
PRD534141 · Product
- Active substance
- Water for Injection
- Pharmaceutical form
- SOLVENT FOR PARENTERAL USE
- Route of administration
- TOPICAL
- Max daily dose
- 250 µl microlitre(s)
- Max total dose
- 250 µl microlitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- 6724092.00.00
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB72702 · Substance
- Active substance
- Sodium Laurilsulfate
- Pharmaceutical form
- CUTANEOUS SOLUTION
- Route of administration
- TOPICAL
- Max daily dose
- 250 µl microlitre(s)
- Max total dose
- 250 µl microlitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD533923 · Product
- Active substance
- Glycerol
- Pharmaceutical form
- CREAM
- Route of administration
- TOPICAL
- Max daily dose
- 4 ml millilitre(s)
- Max total dose
- 196 ml millilitre(s)
- Max treatment duration
- 7 Week(s)
- Authorisation status
- Authorised
- ATC code
- D02AX — OTHER EMOLLIENTS AND PROTECTIVES
- Marketing authorisation
- 16221
- MA holder
- ACO HUD NORDIC AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
ACO Hud Nordic AB
- Sponsor organisation
- ACO Hud Nordic AB
- Address
- P. O. Box 622
- City
- Upplands Vasby
- Postcode
- 194 26
- Country
- Sweden
Scientific contact point
- Organisation
- ACO Hud Nordic AB
- Contact name
- Tina Holm
Public contact point
- Organisation
- ACO Hud Nordic AB
- Contact name
- Tina Holm
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Clinical Microbiomics, Symbion ORL-000002759
|
Copenhagen, Denmark | Code 11, Laboratory analysis |
| SGS proderm GmbH ORG-100032457
|
Schenefeld, Germany | On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 2, Code 5, Data management, E-data capture |
| Myonex GmbH ORG-100043534
|
Berlin, Germany | Code 14 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 55 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
SGS proderm GmbH
Clinical Research Unit, Kiebitzweg 2, 22869, Schenefeld
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2023-12-07 | 2024-03-14 | 2024-01-22 | 2024-01-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Moisturiser effect on the skin barrier in atopic dermatitis_Summary of results SUM-74952
|
2025-03-14T16:56:46 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Moisturiser effect on the skin barrier in atopic dermatitis_lay person summary | 2025-03-14T16:58:18 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | ATOMIC_Lay summary | 1 |
| Summary of results (for publication) | ATOMIC_Summary report | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-08 | Germany | Acceptable 2023-12-06
|
2023-12-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-01-29 | Germany | Acceptable 2023-12-06
|
2024-01-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-19 | Germany | Acceptable 2024-04-08
|
2024-04-15 |