Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream Intended for Very Dry, Irritated to Atopic Sensitive Skin.

Atopic Dermatitis Clinical Trial

Official title:

Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream Intended for Very Dry, Irritated to Atopic Sensitive Skin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05575882
• Other study ID #: RC2022/PSagc/SG-AR
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2022
• Est. completion date: May 2024

Study information

• Verified date: March 2023
• Source: NAOS Argentina S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multicentric, double blind, randomized, comparative study with two parallel group: study group vs placebo group. 5 visits: inclusion visit [day (D) 0] and 4 follow-up visits (D30, D60, D90, and D120).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 15 Years

Eligibility

Inclusion Criteria:

• General criteria:

Healthy subject (except AD and other atopic diseases - allergic rhinitis, conjunctivitis, and asthma). The subject can keep its usual treatment (antihistamines, inhaled corticosteroids, and antileukotriene treatment) during the study if applicable. Written informed consent from the subject's parent(s)/legal representative(s) and children over 8 years old (specific Argentina) and over 12 years old (specific Singapore). Subject accepting to continue the normal conditions of hygiene and sunscreen (if applicable). Subject, parents/legal representative(s) willing to adhere to the study protocol and procedures.

Specific criteria:

Sex: male or female. Age: from 6 months to 15 years. Subject having on average one flare-up per month during the four months preceding the study, including the one observed on the inclusion visit D0. Subject having EASI value from 7.1 - 21 on D0 (moderate AD). Subject having one atopic eruption on the inclusion visit which the dermatologist will prescribe topical corticosteroids or calcineurin's inhibitors (pimecrolimus and/or tacrolimus).

Exclusion Criteria:

• Subject presenting cutaneous pathology in the studied zone other than AD (according to the investigator's appreciation, i.e., acne, psoriasis). Subject using systemic treatment, including oral steroids and oral immunosuppressants e.g., ciclosporin during the previous weeks liable to interfere with the assessment of the cutaneous tolerance of the study product or placebo (according to the investigator's appreciation). Subject using skin-moisturizing products from inclusion (D0) other than the study product or placebo. Subject who had systemic therapy with immune-suppressive drugs and antibiotics within the last 14 days before the beginning of the study Subject having serious illness that might require regular systemic medication (e.g., insulin-dependent diabetes, cancer) or conditions that exclude a participation or might influence the study evaluation. Subject with documented allergies to the study product or placebo ingredients. Subject enrolled in another clinical study during the study period. Parent(s)/legal representative(s) considered by the investigator to be likely not compliant to the protocol.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema, Atopic

Intervention

Other:
• Skin hydration
Skin hydration outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
• Barrier function measurement
TEWL measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
• Potential of hydrogen measurement (pH)
pH measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.
• Clinical evaluation of atopic dermatitis
EASI score on each visit. Non invasive technique.
• Quality of life assessment
Cardiff questionnaires to assess quality of life of subjects and their family members.
• Assessment of the effect on itching and sleep disturbances
Visual analogue scale from 0 to 10
• Assessment of the tolerance of the study product or placebo
By collection of Adverse Events (AEs) on daily log and electronic Case Report Form (eCRF).

Locations

Country	Name	City	State
Argentina	Cirec Latam	Ciudad Autónoma de Buenos Aire
Singapore	KK Women's & Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
NAOS Argentina S.A.

Countries where clinical trial is conducted

Argentina,  Singapore, 

References & Publications (1)

Gayraud F, Sayag M, Jourdan E. Efficacy and tolerance assessment of a new type of dermocosmetic in infants and children with moderate atopic dermatitis. J Cosmet Dermatol. 2015 Jun;14(2):107-12. doi: 10.1111/jocd.12145. Epub 2015 Mar 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of acute flares of eczema in patients with chronic atopic dermatitis (AD)	Clinical evaluation by dermatologist on each visit and daily log statements by the parents.	4 months
Secondary	Change of Atopic Dermatitis using the Eczema Area and Severity Index (EASI)	Clinical evaluation by dermatologist on each visit. Minimum value: 0; maximum value:72. Higher scores mean worse outcome.	0-30, 31-60, 61-90 and 91-120 days of treatment
Secondary	Change of Atopic Dermatitis using the Investigator's Global Assessment (IGA)	Clinical evaluation by dermatologist on each visit. Minimum value: 0; maximum value:4. Higher scores mean worse outcome.	0-30, 31-60, 61-90 and 91-120 days of treatment
Secondary	Tolerance of the study product or placebo	Collection of treatment-related adverse events during the study	0-30, 31-60, 61-90 and 91-120 days of treatment
Secondary	Change of stratum corneum (SC) hydration.	Measurement performed with -Corneometer® CM825 (Courage + Khazaka) and MPACT + software (Monaderm). Subjects must not have applied anything to the forearms on the morning of the measurements. Subject acclimatize for at least 15 minutes in the lab under standardised conditions, with bare test area: - room temperature: 20-22°C; - relative humidity: 40-60%. Dry skin area (the same in all visits): the most recommended area are the forearms (avoid flare-up areas). Minimum value: 0; maximum value:60. Higher scores mean better outcome.	0-30, 31-60, 61-90 and 91-120 days of treatment
Secondary	Change on the trans-epidermal water loss (TEWL).	Measurement performs with - Tewameter® TM Hex (Courage & Khazaka) and MPACT + software (Monaderm). Subjects must not have applied anything to the forearms on the morning of the measurements. Subject acclimatize for at least 15 minutes in the lab under standardised conditions, with bare test area: - room temperature: 20-22°C; - relative humidity: 40-60%. Dry skin area (the same in all visits): the most recommended area are the forearms (avoid flare-up areas). Minimum value: 0; maximum value:20. Higher scores mean worse outcome.	0-30, 31-60, 61-90 and 91-120 days of treatment
Secondary	Change on the pH.	Measurement perform with LAQUA pHmeter PHD72G. Subject must not have applied anything to the forearms on the morning of the measurements. Subject acclimatize for at least 15 minutes in the lab under standardised conditions, with bare test area: - room temperature: 20-22°C; - relative humidity: 40-60%. Dry skin area (the same in all visits): the most recommended area are the forearms (avoid flare-up areas). Minimum value: 0; maximum value:14. pH higher than 5,9 or lower than 4,5 scores mean worse outcome.	0-30, 31-60, 61-90 and 91-120 days of treatment
Secondary	Change on itching	Interview by dermatologist on each visit. Minimum value: 0; maximum value:10. Higher scores mean worse outcome.	0-30, 31-60, 61-90 and 91-120 days of treatment
Secondary	Change on sleep disturbances.	Interview by dermatologist on each visit. Minimum value: 0; maximum value:10. Higher scores mean worse outcome.	0-30, 31-60, 61-90 and 91-120 days of treatment
Secondary	Change on quality of life.	Cardiff quality of life questionnaires fill in by subjects or parents according to age range. The total score is calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The questionnaires can also be expressed as a percentage of the maximum possible score of 30.	0-30, 31-60, 61-90 and 91-120 days of treatment
Secondary	Subjective appreciation of efficacy and acceptability by the parent(s)/legal representative(s) and/or their child.	Questionnaire fill in by representative(s) and/or their child. Score from "totally agree" to "totally disagree". "Totally agree" and "agree" are considered positive answers (in percentage). Somewhat agree and and totally disagree are considered negative answers (in percentage). The questionnaires are expressed as a percentage.	120 days