Moisturiser effect on atopic dermatitis relapse prevention in children

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Aco Hud Nordic AB

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

13 Feb 2023 → 2 May 2024

Decision date (initial)

2022-12-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2022-501184-41-00

WHO UTN

U1111-1281-4454

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Prophylaxis, Therapy

To demonstrate superiority of a newly developed moisturiser in preventing eczema relapse in children with AD compared to a reference cream.

Secondary objectives 7

1. To study the disease severity during different stages of AD (i.e. cleared eczema vs. relapse), as evaluated by investigator, participants and participants’ parent(s) and/or legal guardian(s)
2. To investigate the quality of life during different stages of AD
3. To assess participant/parent satisfaction
4. To assess the cosmetic/organoleptic properties of the investigational products
5. To investigate the number of participants with FLG loss-of-function mutations and explore if there is any evidence of a relationship to treatment effects
6. To explore microbiome in the different stage of AD (cleared vs relapsed AD) and how IP and reference product affects skin microflora over time
7. To assess tolerability and safety of the investigational products

Conditions and MedDRA coding

atopic dermatitis/eczema

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-002511-PIP02-19

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Children >2- ≤12 years old (male and female)
2. Diagnosis of AD according to UK working party 1994,(32) i.e.: a) Any itching skin condition and b) Three or more of the following: (i) History of flexural involvement, e.g. front of elbows, behind the knees, front of ankles, around the neck (ii) Personal history of other atopic disease, e.g. asthma or hay fever (iii) History of generally dry skin in the last 12 months (iv) Visible flexural dermatitis, e.g. front of elbows, behind the knees, front of ankles, around the neck (v) Onset below age 2
3. Visible mild (≤ 15 ) to moderate (> 15 to < 40) eczema according to the objective SCORAD, which ideally should be symmetrical in localization and/or face.
4. Participants with at least two relapses during last 12 months, including the one at the screening visit
5. Participants willing to agree to avoid any other prescription/OTC/natural remedies treatments for eczema and/or dry skin
6. Legally acceptable representatives (i.e. parent(s) or guardians) of participant according to local regulations have provided the appropriate written informed consent and participant has given their assent (as age appropriate).

Exclusion criteria 22

1. Participants with severe eczema, as defined by objective SCORAD
2. Participants with eczema on the hands only
3. Participants with known or suspected allergies or contraindications to any of the study product ingredients (including products for the treatment in the stabilization phase)
4. Participants/participants’ parent(s) and/or legal guardian(s) who, in the opinion of the Investigator, are unable to complete all study related visits and/or procedures.
5. Pregnancy confirmed by a positive human chorionic gonadotropin (hCG) urine test for females of childbearing potential
6. Enrolment in any investigational study or use of an investigational product (oral or topical) within 3 months prior to the screening visit
7. Planning to participate in any other clinical study during participation in this current study, including the maintenance phase.
8. Participants unwilling to refrain from using prohibited medication including moisturizers (other than the study treatments)
9. Antibiotic, antimycotic or antiviral treatment (oral or topical) within 2 weeks prior screening and throughout the study
10. Any treatment with immunomodulatory systemic medications, e.g. dupilumab, omalizumab or other biologics, JAK inhibitors, methotrexate, cyclosporine, oral or systemic corticosteroids (except inhaled corticoid spray for allergic asthma if on a stable dose and asthma status well controlled) within 3 months prior screening and throughout the study
11. Any treatment with TCS' (other than the corticosteroids prescribed in the stabilisation phase) or other established topical treatment for AD within 2 weeks prior screening and throughout the study.
12. Phototherapy (UVB, UVA, UVA1, PUVA) within 4 weeks prior screening and throughout the study
13. Moisturisers, home remedies or other topical products on the study area eczemas, except for the AxMP (during the stabilisation phase) and the IP in the maintenance phase.
14. Asthma which is not stable during the last 6 months prior screening as per clinical judgement (reflected by symptoms>2 days per week or nighttime awakening with symptoms > 2 times per week or reduced normal activities due to asthma, PEF <80% of predicted value)
15. Any infectious disease of the skin within 4 weeks prior screening
16. Viral diseases (e.g. chicken pocks, shingles), rosacea, perioral dermatitis, ulcers, acne vulgaris,skin atrophy, vaccination reaction in the treatment area
17. Skin infections caused by bacteria and fungi
18. Diaper rash in the treatment area
19. Any infectious disease including unexplained diarrhea within 2 weeks prior screening
20. Any immunosuppression or history of unusual frequent, recurrent, severe or prolonged infections
21. History of immunomodulatory or immunosuppressant diseases e.g. lymphoproliferative diseases, diabetes mellitus, malignancies of any organ within 5 years prior screening
22. History of intolerance to topical corticosteroids or any condition which prohibits or does not recommend treatment with topical corticosteroids e.g. atrophy of the skin

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Relapse of atopic eczema, measured as a hazard ratio. Definition of relapse is an episode that, from the participants/participants’ parent(s) and/or legal guardian(s)’s perspective, requires escalation of treatment of the study area eczemas. Date of relapse will be noted in the eDiary and confirmed by the Investigator.

Secondary endpoints 14

1. Time to relapse of atopic eczema (days)
2. Proportion of participants still eczema free after 1, 2, 3, 4, 5 and 6 months maintenance treatment
3. Absolute and relative risk reduction
4. Assessment of disease severity using PO-SCORAD, and POEM (visits 1-4)
5. Assessment of peak itch intensity by VAS obtained from PO-SCORAD (Visits 1-4)
6. Weekly assessment of disease severity by using RECAP during the maintenance phase
7. Quality of life, assessed by disease specific instruments using IDQoL (below four years) or CDLQI (above four years) (Visits 1-4)
8. Quality of life, assessed by general instrument EQ-5D-Y (participants above four years) (Visits 1-4)
9. Cream consumption, based on weight of IP product before and after use (Visit 2 and Visit 4)
10. Questionnaire for evaluation of cosmetic/organoleptic properties of the creams by participant or parents/guardians
11. Questionnaire connected to microbiome for those consenting for microbiome swabbing
12. Number of participants with FLG loss-of-function mutations and evidence of a relationship to treatment effects
13. Tolerability, measured as smarting/stinging on a VAS immediately and 5 minutes after first application (V2) and after one week of treatment
14. Number of participants with Treatment-Emergent Adverse Events (AEs) [Time Frame: Baseline (Day 1) up to Day 180/relapse]

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Auxiliary 3

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 2

Locations

2 EU/EEA countries · 10 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

6 submissions — initial application plus substantial / non-substantial modifications