Cosmetic cream for treating very dry and irritated skin in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cidp
  New Delhi, India Recruiting
• Cirec Latam
  Ciudad Autónoma de Buenos Aire, Ciudad Autónoma de Buenos Aire, Argentina Not yet recruiting
• KK Women's & Children's Hospital
  Singapore, Singapore, Singapore Suspended

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Camoteskimab in adults with moderate-to-severe atopic dermatitis

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• Soquelitinib for adults with moderate to severe atopic dermatitis

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• A medicine for eczema: see if PF-08049820 helps adults with moderate to severe atopic dermatitis

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  Recruiting at 41 sites Phase 2 Pfizer · Phoenix, Arizona and 51 other locations · NCT07216027

• Testing a new hydrogel for treating mild to moderate eczema

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  Recruiting at 12 sites Phase 2 Alphyn Biologics · Brookvale, New South Wales and 11 other locations · NCT06855745

• Roflumilast Cream 0.3% for moderate to severe atopic dermatitis in children, adolescents, and adults

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  Recruiting at 4 sites Phase 3 Arcutis Biotherapeutics, Inc. · Birmingham, Alabama and 3 other locations · NCT07916480

• Nocturnal ScratchSense ring: test of automatic scratch detection in adults with itchy skin

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  Recruiting Replior AB · Grenoble · NCT07909967

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.