NCT05259774: YOUNG

Clinical Investigation on the Efficacy and Safety of Relizema Cream in Paedriatric Patients

Completed NA Results posted Last updated 28 March 2025

What this trial tests

NA trial testing Relizema cram in Atopic Dermatitis in 60 participants. Completed in 9 June 2023.

Timeline

27 October 2022

Primary endpoint
9 June 2023

9 June 2023

Quick facts

Lead sponsor	Relife S.r.l.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	27 October 2022
Primary completion	9 June 2023
Estimated completion	9 June 2023
Sites	1 location across Italy

Drugs / interventions tested

• Relizema cram

Conditions studied

• Atopic Dermatitis — all drugs for Atopic Dermatitis →

Sponsor

Relife S.r.l.

Who can join

Adults 6 Months to 17, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

To Evaluate and Confirm the Performance of the Relizema Cream in the Improvement of the Dermatitis Severity in Paediatric Patients. Primary · 28 days of treatment

The disease severity will be clinically measured through the Investigator Global Assessment (IGA) for dermatitis after 28 days of treatment, compared to vehicle.

Group	Value	95% CI
Relizema Cream	17
Vehicle	13

To Evaluate the Performance of the Relizema Cream, Compared to Placebo, Secondary · after 14 and 42 days of treatment, 42 days reported

To evaluate the performance of the Relizema cream, compared to placebo, in the improvement of dermatitis severity (IGA) after 14 and 42 days of treatment

Group	Value	95% CI
Relizema Cream	12
Vehicle	10

To Evaluate the Eczema Improvement Secondary · after 14, 28 and 42 days of treatment, reported after 42 days

To evaluate the eczema improvement through the EASI (Eczema Area and Severity Index) score

Group	Value	95% CI
Relizema Cream	18
Vehicle	14

To Evaluate the Media in Itching, Burning, Pain and Pruritus at Visits Secondary · after 14, 28 and 42 days of treatment, day 42 reported

To evaluate itching as reported by the patient at visits by the Numerical Rating Scale (NRS that is a numeric scale from 0 to 10, 0 is the best result, 10 is the worst), in the two treatment groups

Group	Value	95% CI
Relizema Cream	5.45	± 6.62
Vehicle	4.31	± 6.26

To Evaluate Improvement in the Quality of Life (QoL) of the Subject Related to His/Her Dermatitis Secondary · after 14, 28 and 42 days of treatment, reported 42 days

To evaluate the QoL improvement of the patient related to his/her dermatitis, through the Children Dermatology Life Quality Index (CDLQI) questionnaire in the two treatment groups; The questionnaire asks for 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on q

Group	Value	95% CI
Relizema Cream	2.42	± 1.67
Vehicle	1.83	± 1.86

To Evaluate the Patient's Adherence to Treatment Secondary · 42 days

Units on a scale of partecipants with an improvement in the dermatitis severity

Group	Value	95% CI
Relizema Cream	97.46	± 5.13
Vehicle	96.96	± 7.32

To Evaluate the Need of a Rescue Treatment (as Indicated by the Investigator) to Manage AD Flare; Secondary · 42 days of treatment

To evaluate the need of a rescue treatment (as indicated by the Investigator) to manage AD flare;

Group	Value	95% CI
Relizema Cream	21
Vehicle	16

To Evaluate the Patient's Global Evaluation of Performance of Relizema Cream, Compared to Placebo Secondary · at the end of the study ( day 42)

To evaluate the patient's global evaluation on performance of the study product performed by means of a 7-items scale (where 1 = very much improved, 2 = improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = worse, 7 = very much worse)

Group	Value	95% CI
Relizema Cream	5.29	± 4.73
Vehicle	3.53	± 4

Sponsor's own description

The scope of this multicenter, double blind, randomized, vehicle-controlled clinical investigation is to evaluate and confirm the performance and safety of the Relizema cream in the improvement of the dermatitis severity in paediatric patients. The disease severity will be clinically measured through the Investigator Global Assessment (IGA) after 42 days of treatment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. New and Upcoming Topical Treatments for Atopic Dermatitis: A Review of the Literature.
   Sideris N, Paschou E, Bakirtzi K, Kiritsi D, et al · · 2022 · cited 28× · PMID 36078904 · DOI 10.3390/jcm11174974