Trial document





This trial has been registered retrospectively.
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  DRKS00009503

Trial Description

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Title

Dermatological use test in the diaper area with Protective Balm WO 3396 on babies and toddlers

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In this study, 32 babies/toddlers were treated with Protective Balm WO 3396 for 4 weeks. The balm was used in the area under disposable diapers. The safety and efficacy regarding protective and regenerative properties of the balm on irritated skin was evaluated in the diaper skin area.

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Brief Summary in Scientific Language

A total of 32 children were enrolled (16 male, 16 female; age: 15,0±7,7 months) in this open-labeled clinical study. The test product (Protective Balm WO 3396) was used in the area under disposable diapers at least after each diaper change and even more often if required, according to the respective needs and normal using habits. The duration of treatment was 4 weeks. At the beginning, as well as after 4 weeks of treatment, erythema, dryness, scaling, fissures, papules, pustules, edema, vesicles, and weeping were assessed as objective parameters by a pediatrician. Subjective assessment of product properties by subject's parents was performed by subject questionnaire.

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Organizational Data

  •   DRKS00009503
  •   2015/10/16
  •   [---]*
  •   no
  •   Approved
  •   012/1238, Freiburger Ethik-Kommission International
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Secondary IDs

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Health Condition or Problem studied

  •   L22 -  Diaper [napkin] dermatitis
  •   Diaper rash
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Interventions/Observational Groups

  •   Protective Balm WO 3396, topical application, ad libitum, for 4 weeks
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Tolerability: assessment of objective skin parameters by a pediatrician at the beginning and after 4 weeks of treatment

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Secondary Outcome

Cosmetic acceptance: evaluation of product properties after the study (parents' questionnaire)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2013/05/07
  •   32
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   6   Months
  •   30   Months
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Additional Inclusion Criteria

Wearing of disposable diapers,
Regular users of protective balm/cream

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Exclusion Criteria

Documented allergies to cosmetic products,
active skin dieseases at test area,
not using diaper during the day and night,
application of other skin care products at the test area, participation in similar cosmetic and/or pharmaceutical studies

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Dr. August Wolff GmbH & Co. KG Arzneimittel
    • Sudbrackstr. 56
    • 33611  Bielefeld
    • Germany
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    • Dr. August Wolff GmbH & Co. KG Arzneimittel
    • Mr.  Dr.  Sören  Merker 
    • Sudbrackstraße 56
    • 33611  Bielefeld
    • Germany
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    • proDERM Institut für AngewandteDermatologische Forschung GmbH
    • Mr.  Stephan  Bielfeldt 
    • Kiebitzweg 2
    • 22869  Schenefeld/Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Dr. August Wolff GmbH & Co. KG Arzneimittel
    • Sudbrackstr. 56
    • 33611  Bielefeld
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/06/04
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.