Cosmetic cream for treating very dry and irritated skin in children
Anti-relapse Efficacy and Tolerance Assessment of a Cosmetic Cream Intended for Very Dry, Irritated to Atopic Sensitive Skin
This study is testing a new cream for children with very dry and irritated skin to see if it helps improve their skin condition better than a fake cream.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 6 Months to 15 Years |
| Sex | All |
| Sponsor | NAOS Argentina S.A. Industry-sponsored |
| Locations | 3 sites (Ciudad Autónoma de Buenos Aire, Ciudad Autónoma de Buenos Aire and 2 other locations) |
| Trial ID | NCT05575882 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of a cosmetic cream designed for children with very dry, irritated skin, specifically those suffering from atopic dermatitis. It is a multicentric, double-blind, randomized study that includes two groups: one receiving the cream and the other a placebo. Participants will undergo five visits over a 120-day period to assess skin hydration, barrier function, pH levels, and overall quality of life. The study will take place in Argentina and India, enrolling a total of 100 patients aged 6 months to 15 years.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 months to 15 years with moderate atopic dermatitis experiencing monthly flare-ups.
Not a fit: Patients with severe atopic dermatitis or those not experiencing regular flare-ups may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the skin condition and quality of life for children suffering from atopic dermatitis.
How similar studies have performed: While there have been studies on topical treatments for atopic dermatitis, this specific approach using a cosmetic cream is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ciudad Autónoma de Buenos Aire, Ciudad Autónoma de Buenos Aire and 2 other locations
- Cirec Latam — Ciudad Autónoma de Buenos Aire, Ciudad Autónoma de Buenos Aire, Argentina (Not_yet_recruiting)
- Cidp — New Delhi, India (Recruiting)
- KK Women's & Children's Hospital — Singapore, Singapore, Singapore (Suspended)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.