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OpenTrials
Completed

NCT Number: NCT02615561

Curing Atopic Dermatits in Children With a Commerical Medical Device and Maintaining Healthy Skin by Using a New Cosmetic Product

1. Curing mild atopic dermatis in children with a commerical medical device (Bepanthen Itch Relief Cream). 2. Maintaining healthy skin by using a new cosmetic Bepanthen product or a commercially available cosmetic product

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Key information

Conditions

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

Age range

1 month–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karlsruhe, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written parents' informed consent to have their child participate in the study and attend the study procedures and processes as outlined in the protocol
  • Male or female babies/children aged between 1 month and 4 years
  • Mild AD presenting a maximum SCORAD of 25 (at Screening and Baseline)
  • Acute flare-up phase
  • Local SCORAD ≥ 5 on the target area (at Screening and Baseline)
  • Skin type I - IV according to Fitzpatrick

Exclusion criteria

  • Any other skin disease at the target area that would interfere the clinical assessment in the opinion of the investigator
  • Known allergies to any of the ingredients of the IMPs
  • Any other adjuvant therapy for AD (UV therapy, probiotics, homeopathy etc.) within 30 days before Baseline as well as during the entire study
  • Any use of another topical emollient or other established treatment for AD during Phase 1 (cure phase) and Phase 2 (care phase) at the site of flares (AD lesions). Exception are usual hygienic products in the nappy area

Treatment and study plan

Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543)

Device

2-3 times daily using multiples of Finger Tip Units (FTUs) depending on size of the area of the flares

New cosmetic Bepanthen product: Pumpkin (BAY207543)

Other

Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject

Stelatopia (cosmetic comparator)

Other

Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject

Primary outcomes

  1. Efficacy: SCORAD with included parameters "extent of disease/area affected" [%] as well as average intensity of pruritus and sleeplessness

    Time frame: up to 3 months

  2. Efficacy: Local SCORAD including single symptoms erythema, edema/ papulation, excoriation, lichenification, oozing/crusts, dryness

    Time frame: up to 3 months

  3. Efficacy: Quality of Life according to questionnaire

    Time frame: up to 3 months

  4. Efficacy: Intensity of pruritus according to diary

    Time frame: up to 3 months

  5. Efficacy: Intensity of sleeplessness according to diary

    Time frame: up to 3 months

  6. Efficacy: Responder rate: No. of subjects with local SCORAD <5 (Phase 1, only)

    Time frame: up to 3 months

  7. Efficacy: Time to flare-up (Phase 2, only)

    Time frame: up to 3 months

  8. Efficacy: Percent of subjects with flare-up (Phase 2, only)

    Time frame: up to 3 months

Secondary outcomes

  1. Safety: Number of adverse events (AE)

    Time frame: up to 3 months

  2. Safety: physical examination

    Time frame: up to 3 months

    Weight and height

  3. Safety: vital signs

    Time frame: up to 3 months

    Systolic and diastolic blood pressure, Heart rate

  4. Safety: Local tolerability (by AE assessment)

    Time frame: up to 3 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Multicenter, Two-phase Exploratory Clinical Trial to Examine Efficacy and Safety After Open-label Topical Administration of a Medical Device (Bepanthen Itch Relief Cream) for Treatment of Acute Flare-ups Followed by Topical Administration of a New Cosmetic Bepanthen Product or a Cosmetic Comparator in a Parallel-group, Randomized, Investigator-blinded Care Phase for Skin Care in the Remission Phase in Infants With Mild Atopic Dermatitis

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 26, 2015
Registry last updated
Sep 15, 2017

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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