Atopic DermatitisNCT05783453
CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS
An observational study of Atopic Dermatitis, run by Cosmetique Active International at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Cosmetic study
- How many people
- 63 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Dec 2021to 22 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Child, Adult, Older adult
Study population: children and adult subjects with mild atopic dermatitis
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS: REDUCTION OF CRISES AND MAINTENANCE OF TREATMENT. STUDY UNDER NORMAL CONDITIONS OF USE AND DERMATOLOGICAL SUPERVISION
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
Read more
- 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
- Atopic Dermatitis
- Being tested
- Cosmetic study
- Keywords
- atopic dermatitis, eczema, emollient
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic studyOther
Also called Emollient
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 168
Secondary outcomes (41)
Flares
Evaluation of flares quantity and severity on a scale 0=none to 4=severe
Measured: Baseline
Flares
Evaluation of flares quantity and severity on a scale 0=none to 4=severe
Measured: Day 84
Flares
Evaluation of flares quantity and severity on a scale 0=none to 4=severe
Measured: Day 168
Skin parameters
Improvement on a scale 0=none to 4=severe
Measured: Baseline
Skin parameters
Improvement on a scale 0=none to 4=severe
Measured: Day 14
Skin parameters
Improvement on a scale 0=none to 4=severe
Measured: Day 28
Skin parameters
Improvement on a scale 0=none to 4=severe
Measured: Day 84
Skin parameters
Improvement ona scale0=none to 4=severe
Measured: Day 156
Product acceptability
Subject questionnaire
Measured: Day 14
Product acceptability
Subject questionnaire
Measured: Day 28
Product acceptability
Subject questionnaire
Measured: Day 84
Product acceptability
Subject questionnaire
Measured: Day 156
Skin hydration
Transepidermal water loss using tewameter
Measured: Baseline
Skin hydration
Transepidermal water loss using tewameter
Measured: Day 14
Skin hydration
Transepidermal water loss using tewameter
Measured: Day 28
Skin hydration
Transepidermal water loss using tewameter
Measured: Day 84
Skin hydration
Transepidermal water loss using tewameter
Measured: Day 156
Skin moisturizing
Moisturising effect using corneometer
Measured: Baseline
Skin moisturizing
Moisturising effect using corneometer
Measured: Day 14
Skin moisturizing
Moisturising effect using corneometer
Measured: Day 28
Skin moisturizing
Moisturising effect using corneometer
Measured: Day 84
Skin moisturizing
Moisturising effect using corneometer
Measured: Day 156
Folliculitis
scale 0=none to 4=severe
Measured: Baseline
Folliculitis
scale 0=none to 4=severe
Measured: Day 14
Folliculitis
scale 0=none to 4=severe
Measured: Day 28
Folliculitis
scale 0=none to 4=severe
Measured: Day 84
Folliculitis
scale 0=none to 4=severe
Measured: Day 156
Evolution of Quality of life over time
DLQI (Dermatology Life Quality Index) questionnaire
Measured: Baseline
Evolution of Quality of life over time
DLQI (Dermatology Life Quality Index) questionnaire
Measured: Day 14
Evolution of Quality of life over time
DLQI (Dermatology Life Quality Index) questionnaire
Measured: Day 28
Evolution of Quality of life over time
DLQI (Dermatology Life Quality Index) questionnaire
Measured: Day 84
Evolution of Quality of life over time
DLQI (Dermatology Life Quality Index) questionnaire
Measured: Day 156
local tolerance reporting
reporting of events
Measured: Day 14
local tolerance reporting
reporting of events
Measured: Day 28
local tolerance reporting
reporting of events
Measured: Day 84
local tolerance reporting
reporting of events
Measured: Day 156
Total body dryness
scale
Measured: Baseline
Total body dryness
scale
Measured: Day 14
Total body dryness
scale
Measured: Day 28
Total body dryness
scale
Measured: Day 84
Total body dryness
scale
Measured: Day 156
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start20 Dec 2021
- Primary completion22 Jul 2022
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniele Miranda, MD, Study director, CIDP Brasil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783453
- Sponsor's protocol ID
- 2122CBCL002
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cestari S, Correia P, Kerob D. Emollients "Plus" are Beneficial in Both the Short and Long Term in Mild Atopic Dermatitis. Clin Cosmet Investig Dermatol. 2023 Aug 8;16:2093-2102. doi: 10.2147/CCID.S417622. eCollection 2023.
PubMed 37575149
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINICAL EFFICACY OF EMOLLIENTS IN ATOPIC DERMATITIS PATIENTS: REDUCTION OF CRISES AND MAINTENANCE OF TREATMENT. STUDY UNDER NORMAL CONDITIONS OF USE AND DERMATOLOGICAL SUPERVISION
- ClinicalTrials.gov ID
- NCT05783453
- Acronym / sponsor ID
- 2122CBCL002
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, eczema, emollient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- children and adult subjects with mild atopic dermatitis
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cosmetic studyAlso: EmollientLIPIKAR 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 | Other | – |
Primary outcome
Improvement of SCORAD Score
Time frame: baseline
Decrease of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use
Improvement of SCORAD Score
Time frame: Day 14
Decrease of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use
Improvement of SCORAD Score
Time frame: Day 28
Decrease of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use
Improvement of SCORAD Score
Time frame: Day 84
Maintenance of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use
Improvement of SCORAD Score
Time frame: Day 168
Maintenance of SCORAD in child and adult subjects with mild atopic dermatitis after 14 and 28 days under normal conditions of use
41 secondary outcomes
Flares
Time frame: Baseline
Flares
Time frame: Day 84
Flares
Time frame: Day 168
Skin parameters
Time frame: Baseline
Skin parameters
Time frame: Day 14
Skin parameters
Time frame: Day 28
Skin parameters
Time frame: Day 84
Skin parameters
Time frame: Day 156
Product acceptability
Time frame: Day 14
Product acceptability
Time frame: Day 28
Product acceptability
Time frame: Day 84
Product acceptability
Time frame: Day 156
Skin hydration
Time frame: Baseline
Skin hydration
Time frame: Day 14
Skin hydration
Time frame: Day 28
Skin hydration
Time frame: Day 84
Skin hydration
Time frame: Day 156
Skin moisturizing
Time frame: Baseline
Skin moisturizing
Time frame: Day 14
Skin moisturizing
Time frame: Day 28
Skin moisturizing
Time frame: Day 84
Skin moisturizing
Time frame: Day 156
Folliculitis
Time frame: Baseline
Folliculitis
Time frame: Day 14
Folliculitis
Time frame: Day 28
Folliculitis
Time frame: Day 84
Folliculitis
Time frame: Day 156
Evolution of Quality of life over time
Time frame: Baseline
Evolution of Quality of life over time
Time frame: Day 14
Evolution of Quality of life over time
Time frame: Day 28
Evolution of Quality of life over time
Time frame: Day 84
Evolution of Quality of life over time
Time frame: Day 156
local tolerance reporting
Time frame: Day 14
local tolerance reporting
Time frame: Day 28
local tolerance reporting
Time frame: Day 84
local tolerance reporting
Time frame: Day 156
Total body dryness
Time frame: Baseline
Total body dryness
Time frame: Day 14
Total body dryness
Time frame: Day 28
Total body dryness
Time frame: Day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Derived from this study: PubMed 37575149Cestari S, Correia P, Kerob D. Emollients "Plus" are Beneficial in Both the Short and Long Term in Mild Atopic Dermatitis. Clin Cosmet Investig Dermatol. 2023 Aug 8;16:2093-2102. doi: 10.2147/CCID.S417622. eCollection 2023.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniele Miranda, MD study director
CIDP Brasil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Cosmetique Active International at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of SCORAD Score (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05783453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.