Trial document





This trial has been registered retrospectively.
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  DRKS00009504

Trial Description

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Title

Clinical study to assess efficacy and tolerability of Protective Balm WO 3396 in the anogenital area of women suffering from skin irritation

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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, 43 adult women suffering from skin problems in the outer genital area were treated with Protective Balm WO 3396 for 4 weeks. The product was applied at least once daily on the affected skin area. The tolerability, efficacy and the subjective properties of the product were evaluated both by a physician and by the volunteers.

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Brief Summary in Scientific Language

In this open, 1-armed, multicenter study, 43 women (mean age: 46.2±16.9) with predisposition to skin irritation in the outer anogenital region were treated with Protective Balm WO 3396 in order to test its nourishing and protecting efficacy as well as its tolerability. The product was applied to the outer anogenital area for 28 days one to two times daily, at least after every cleansing. For the assessment of skin tolerability, cometic effect and acceptance of the product, both the physician's and the subject's evaluaion were considered.

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Organizational Data

  •   DRKS00009504
  •   2015/10/16
  •   [---]*
  •   no
  •   Approved
  •   013/1084, Freiburger Ethik-Kommission International
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Secondary IDs

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Health Condition or Problem studied

  •   Skin irritation in the outer anogenital region
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Interventions/Observational Groups

  •   Protective Balm WO 3396, topical application, 1 to 2 times daily as required, for 28 days
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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

Changes in subjective sum scores of symptoms (Day 28 compared to baseline). The sum score consists of single scores concerning the following symptoms: feelings of soreness, burning, stinging, roughness, swelling and itching

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Secondary Outcome

The quality and frequency of adverse events observed during the 4-week treatment.

Changes in objective single scores for the evaluation of the following diagnostic findings in the outer anogenital area by the physician: erythema, swelling, skin shininess, scratching and hyperkeratosis (baseline compared to day 28).

Overall rating of efficacy on day 28 (physician/subjects).

Overall rating of tolerability on day 28 (physician/subjects).

Assessment of product properties on day 28 (subject questionnaire).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2013/03/12
  •   43
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Women with skin irritation in the outer anogenital area

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Exclusion Criteria

Women with skin infection, skin erosion, neoplasia, skin diseases, pregnancy, or hypersensitivity against one of the ingredients as well as women in or after radiotherapy or simultaneous application of another skin protection product

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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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    • Praxis Dr. Küppers
    • Mr.  Priv.-Doz. Dr. med.  Volkmar  Küppers 
    • Königsallee 64
    • 40212  Düsseldorf
    • 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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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2013/11/19
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Trial Publications, Results and other Documents

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