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NCT Number: NCT05575882

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

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).

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Key information

Conditions

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

Age range

6 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cirec Latam, Ciudad Autónoma de Buenos Aire, Argentina

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About this study

This is a prospective, double blind, multicentric and comparative study including 5 visits (on D0 which corresponds to inclusion visit, D30, D60, D90, and D120). It will take place from June 2024 to June 2025 in Argentina (CIREC LATAM, Buenos Aires) and India (CIDP, New Dheli). This study will include 100 patients (50 in India and 50 in Argentina) who will be followed up for 120 days (± 3 days).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Skin hydration

Other

Skin hydration outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.

Other names: Corneometer

Barrier function measurement

Other

TEWL measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.

Other names: Transepidermal Water Loss (TEWL)

Potential of hydrogen measurement (pH)

Other

pH measurement outside flare-up areas on an initial dry skin (the same in each visit). Non invasive technique.

Clinical evaluation of atopic dermatitis

Other

EASI score on each visit. Non invasive technique.

Other names: Eczema Area and Severity Index (EASI)

Quality of Life Assessment

Other

Cardiff questionnaires to assess quality of life of subjects and their family members.

Assessment of the effect on itching and sleep disturbances

Other

Visual analogue scale from 0 to 10

Assessment of the tolerance of the study product or placebo

Other

By collection of Adverse Events (AEs) on daily log and electronic Case Report Form (eCRF).

Primary outcomes

  1. Change of acute flares of eczema in patients with chronic atopic dermatitis (AD)

    Time frame: 4 months

    Clinical evaluation by dermatologist on each visit and daily log statements by the parents.

Secondary outcomes

  1. Change of Atopic Dermatitis using the Eczema Area and Severity Index (EASI)

    Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment

    Clinical evaluation by dermatologist on each visit. Minimum value: 0; maximum value:72. Higher scores mean worse outcome.

  2. Change of Atopic Dermatitis using the Investigator's Global Assessment (IGA)

    Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment

    Clinical evaluation by dermatologist on each visit. Minimum value: 0; maximum value:4. Higher scores mean worse outcome.

  3. Tolerance of the study product or placebo

    Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment

    Collection of treatment-related adverse events during the study

  4. Change of stratum corneum (SC) hydration.

    Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment

    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.

  5. Change on the trans-epidermal water loss (TEWL).

    Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment

    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.

  6. Change on the pH.

    Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment

    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.

  7. Change on itching

    Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment

    Interview by dermatologist on each visit. Minimum value: 0; maximum value:10. Higher scores mean worse outcome.

  8. Change on sleep disturbances.

    Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment

    Interview by dermatologist on each visit. Minimum value: 0; maximum value:10. Higher scores mean worse outcome.

  9. Change on quality of life.

    Time frame: 0-30, 31-60, 61-90 and 91-120 days of treatment

    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.

  10. Subjective appreciation of efficacy and acceptability by the parent(s)/legal representative(s) and/or their child.

    Time frame: 120 days

    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.

Sponsors and collaborators

Lead sponsor

NAOS Argentina S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 12, 2022
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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