Impact of the Daily Use of Emollient on Corticosteroids Consumption in Patients With Atopic Dermatitis

NCT05644691 | Completed

• 1 other identifier: LRP19002-LIPIKAR BAUME AP+M
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims at assessing the reduction of consumption of corticosteroids (same mid-potent corticosteroids for all patients) afforded by the use of a specific emollient in comparison to the usual one in subjects suffering from atopic dermatitis.

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; corticosteroids; SCORAD

Outcome Measures

Primary Outcomes (1)

• efficacy of treatments

  the efficacy of treatments is evaluated by corticosteroids consumption (weight of product and number of applications)

  from baseline to Day84

Secondary Outcomes (9)

• change in SCORing Atopic Dermatitis (SCORAD) measure

  from baseline to Day84

• change in Patient-Oriented SCORing Atopic Dermatitis (PO-SCORAD) measure

  from baseline to Day84

• change in LOCAL SCORing Atopic Dermatitis (LOCAL SCORAD) measure

  from baseline to Day84

• change in cutaneous discomfort

  from baseline to Day84

• change in global efficacy

  from Day28 to Day84

Study Arms (2)

Lipikar Baume AP+M

The group applies Lipikar Baume AP+M twice daily for 3 months. Participants have 4 visits (Day0, Day 28, Day56, Day84) with different outcome measures including self-evaluations).

Other: Lipikar Baume AP+M

Usual emollient

The group applies their usual emollient twice daily for 3 months. Participants have 4 visits (Day0, Day28, Day56, Day84 with different outcome measures including self-evaluations).

Other: Usual emollient

Interventions

Lipikar Baume AP+M OTHER

application of Lipikar Baume AP+M twice daily for 3 months in parallel with the corticosteroid treatment

Lipikar Baume AP+M

Usual emollient OTHER

application of the usual emollient twice daily for 3 months in parallel with the corticosteroid treatment

Usual emollient

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients meeting the inclusion and exclusion criteria and agreeing to participate in the study

You may qualify if:

• diagnosis of atopic dermatitis must meet Hanifin's criteria (at least 3 basic features and at least 3 minor features)
• able to apply the emollient (each morning and evening) during a three-month period

You may not qualify if:

• presenting with another dermatological condition that could interfere with clinical evaluation
• having received any systemic treatment, including PUVAtherapy for atopic dermatitis in the month prior to Day 0
• who intend to expose themselves to the sun during the trial

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (1)

DOST

Svidník, 08901, Slovakia

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Caroline Le Floc'h

  Cosmetique Active International

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 9, 2022
• Study Start: October 14, 2020
• Primary Completion: July 14, 2021
• Study Completion: July 14, 2021
• Last Updated: December 9, 2022

Record last verified: 2022-11

Locations

SL (1)