CompletedNCT05783453Updated Mar 24, 2023

CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS

An observational study in Atopic Dermatitis, sponsored by Cosmetique Active International. Completed at 1 site in Brazil. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2023-03-24.

Sponsored by Cosmetique Active International · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 63
Ages: 3 Years and older
Sex: All

Study summary

his was a monocentric, intra-individual study, that was performed in at least 45 valid cases (50% children ≥3 YO; 50% adults). Study duration was 168 days with five (5) visits (D0, D14, D28, D84 and D168) to the research center.

Primary objective

Evaluation of the efficacy of LIPIKAR BAUME LIGHT AP+M in decrease the SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use;
Evaluation of the efficacy of LIPIKAR BAUME LIGHT AP+M in maintenance the SCORAD value in child and adult subjects with mild atopic dermatitis after 84 and 168 days under normal conditions of use.

Secondary objective

Evaluation of flares quantity and severity during 84 and 168 days of use;
Clinical evaluation of the improvement of skin parameters such as erythema, oedema, oozing, excoriation, lichenification, dryness and desquamation of a lesional and non-lesional skin from the same individual site by dermatologist after 14, 28, 84 and 168 days;
Self-assessment of the improvement of skin parameters such as itching, tingling, burning by subjects after 14, 28, 84 and 168 days;
Evaluate the perceived efficacy, cosmeticity and acceptability through a subjective evaluation questionnaire after 14, 28, 84 and 168 days;
Evaluation of the improvement in skin barrier function by the loss of transepidermic water through instrumental measurements with the Tewameter® equipment on AF and UAF after 14, 28, 84 and 168 days;
Evaluation of the improvement of skin moisturizing through instrumental measurements with Corneometer® equipment on AF and UAF after 14, 28, 84 and 168 days;
The folliculitis incidence after 14, 28, 84 and 168 days;
Assessment of the improvement of the impact of quality of life through a DLQI (Dermatology Life Quality Index) questionnaire after 14, 28, 84 and 168 days;
Assessment of global tolerance through clinical dermatological evaluation and reports performed by the subjects after using the product after 14, 28, 84 and 168 days.
Evaluation of total body skin dryness improvement after 14, 28, 84 and 168 days.
Illustrative clinical pictures of one or two affected areas.

Conditions studied

Atopic Dermatitis

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Keywords

atopic dermatitis, eczema, emollient

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 63 is below the median of 150 across 237 observational studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Cosmetique Active International is the lead sponsor of 54 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 3 Years and older
Sexes eligible: All
Sampling method: Non-probability sample

Study population

children and adult subjects with mild atopic dermatitis

Inclusion criteria

Women or men, from 3 years old, being 50% children (≥3 years old ≤ 11 years and 11 months) and 50% adults;
All phototypes (a good balance between the phototypes is not mandatory, but all phototypes should be included);
Diagnosis of atopic dermatitis must meet Hanifin's criteria (at least 3 basic features and at least 3 minor features);
Subject with mild atopic dermatitis present for at least 6 months before inclusion (SCORAD at inclusion \< 25);
Subjects that have an unchanged AD routine for at least 3 months, including to systematic use of topical or systemic antihistamines, topical or systemic corticoid, cyclosporin A and other immunosuppressant.
Subject able to use the study product at least once a day during all study.
Subject agreeing not to change their lifestyle during the study period (overbathing, being exposed to intense stress as change job, do a fast diet to loose weight...);
Subject agreeing to use only the study product and no other topical treatment for the duration of the study (usual topical or oral treatment for AD is allowed);
Subject capable of reading the documents presented to them, of adhering to the study regulations and accepting the limitations;
Subject available to follow the study;
Subject agreeing to participate and having signed the informed consent;
Subject available to be contacted by phone throughout the study.

Exclusion criteria

Exclusion Criteria:

Breastfeeding, pregnant;
Subject presenting with another dermatological condition that could interfere with clinical evaluation;
Subject presenting a previous history of allergy to cosmetic products;
Subject having received any systemic treatment, including PUVA therapy for atopic dermatitis in the month prior to Day 0;
Subject having received phototherapy within 2 weeks before the first visit;
Subject who intend to excessively expose themselves to the sun during the study;
Subject known allergy to any component of the tested product (subjects will be asked if they have allergies to any ingredients and will be checked in the list if it is contained in the IP);
Subject who have used any experimental treatment within 2 weeks before the first visit;
Subject not presenting with the conditions needed to comply with the protocol;
Subject unable to give their informed consent;
Subject not available to follow the study in its entirety.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 63 participants (actual)
Patient registry: No

Interventions

OtherCosmetic study
LIPIKAR BAUME LIGHT AP+M * Formula: 2039055 06 * Aspect: Emulsion * Batch nº: RAUO0063 * Expiry date: 10/2022 * Application area: Face and Body * Application mode: Apply to face and body twice a day. * Quantity of product to be applied: About 1 flask (400g) per month
Also known as: Emollient

What researchers measure

Primary outcomes

Improvement of SCORAD Score
Decrease of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use
Time frame: baseline
Improvement of SCORAD Score
Decrease of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use
Time frame: Day 14
Improvement of SCORAD Score
Decrease of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use
Time frame: Day 28
Improvement of SCORAD Score
Maintenance of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use
Time frame: Day 84
Improvement of SCORAD Score
Maintenance of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use
Time frame: Day 168

Secondary outcomes

Flares
Evaluation of flares quantity and severity on a scale 0=none to 4=severe
Time frame: Baseline
Flares
Evaluation of flares quantity and severity on a scale 0=none to 4=severe
Time frame: Day 84
Flares
Evaluation of flares quantity and severity on a scale 0=none to 4=severe
Time frame: Day 168
Skin parameters
Improvement on a scale 0=none to 4=severe
Time frame: Baseline
Skin parameters
Improvement on a scale 0=none to 4=severe
Time frame: Day 14
Skin parameters
Improvement on a scale 0=none to 4=severe
Time frame: Day 28
Skin parameters
Improvement on a scale 0=none to 4=severe
Time frame: Day 84
Skin parameters
Improvement ona scale0=none to 4=severe
Time frame: Day 156
Product acceptability
Subject questionnaire
Time frame: Day 14
Product acceptability
Subject questionnaire
Time frame: Day 28
Product acceptability
Subject questionnaire
Time frame: Day 84
Product acceptability
Subject questionnaire
Time frame: Day 156
Skin hydration
Transepidermal water loss using tewameter
Time frame: Baseline
Skin hydration
Transepidermal water loss using tewameter
Time frame: Day 14
Skin hydration
Transepidermal water loss using tewameter
Time frame: Day 28
Skin hydration
Transepidermal water loss using tewameter
Time frame: Day 84
Skin hydration
Transepidermal water loss using tewameter
Time frame: Day 156
Skin moisturizing
Moisturising effect using corneometer
Time frame: Baseline
Skin moisturizing
Moisturising effect using corneometer
Time frame: Day 14
Skin moisturizing
Moisturising effect using corneometer
Time frame: Day 28
Skin moisturizing
Moisturising effect using corneometer
Time frame: Day 84
Skin moisturizing
Moisturising effect using corneometer
Time frame: Day 156
Folliculitis
scale 0=none to 4=severe
Time frame: Baseline
Folliculitis
scale 0=none to 4=severe
Time frame: Day 14
Folliculitis
scale 0=none to 4=severe
Time frame: Day 28
Folliculitis
scale 0=none to 4=severe
Time frame: Day 84
Folliculitis
scale 0=none to 4=severe
Time frame: Day 156
Evolution of Quality of life over time
DLQI (Dermatology Life Quality Index) questionnaire
Time frame: Baseline
Evolution of Quality of life over time
DLQI (Dermatology Life Quality Index) questionnaire
Time frame: Day 14
Evolution of Quality of life over time
DLQI (Dermatology Life Quality Index) questionnaire
Time frame: Day 28
Evolution of Quality of life over time
DLQI (Dermatology Life Quality Index) questionnaire
Time frame: Day 84
Evolution of Quality of life over time
DLQI (Dermatology Life Quality Index) questionnaire
Time frame: Day 156
local tolerance reporting
reporting of events
Time frame: Day 14
local tolerance reporting
reporting of events
Time frame: Day 28
local tolerance reporting
reporting of events
Time frame: Day 84
local tolerance reporting
reporting of events
Time frame: Day 156
Total body dryness
scale
Time frame: Baseline
Total body dryness
scale
Time frame: Day 14
Total body dryness
scale
Time frame: Day 28
Total body dryness
scale
Time frame: Day 84
Total body dryness
scale
Time frame: Day 156

Study locations

1 site

CIDP
Rio de Janeiro, 20231-048, Brazil

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05783453
Lead sponsor: Cosmetique Active International
Responsible party: Sponsor
First posted: Mar 24, 2023
Start date: Dec 20, 2021
Primary completion: Jul 22, 2022
Completion: Jul 22, 2022
Last update: Mar 24, 2023

Study contacts

Daniele Miranda, MD

study director · CIDP Brasil

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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