Trial document





This trial has been registered retrospectively.
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  DRKS00009497

Trial Description

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Title

Evaluation of the Efficacy to Accelerate Skin Repair after SDS-Induced Skin Irritation and Evaluation of the Protective Efficacy of Protective Cream WO 3133

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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 cosmetic study, the nourishing and protecting porperties of Protective Cream WO 3313 on artificially damaged skin of 30 healthy adults were tested. The cream was applied on one forearm of each subject for 14 days twice daily. Before and during the treatment, both forearms were thouroughly washed with a harsh washing solution in order to produce skin irritation. Hydration, redness and roughness of treated skin were measured and compared to untreated skin.

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Brief Summary in Scientific Language

An artificial irritation of the skin by one week washing with sodium dodecyl sulfate (SDS) was performed to mimic epidermal barrier damage and to evaluate the regenerative and protective properties of Protective Cream WO 3313. Thirty healthy participants (17 female, 13 male; age: 44.2±8.3 years) were included in this intraindividual comparison study. The product was applied on the inner forearm for 14 days twice daily. Testing parameters were skin hydration, transepidermal water loss (TEWL), skin redness, and skin roughness. Untreated skin areas served as control.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00009497
  •   2015/10/15
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  •   no
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  •   [---]*, [Da es sich um eine Studie mit kosmetischen Mitteln handelt, deren Rohstoffe als sicher gelten, ist die Begutachtung durch eine Ethikkommission nicht zwingend vorgeschrieben. Somit wurde kein Ethikvotum beantragt.]
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Secondary IDs

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Health Condition or Problem studied

  •   Epidermal barrier damage / skin irritation
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Interventions/Observational Groups

  •   Test area: During the first phase (Day 1–7), the test area was washed once daily with 5% SDS solution. During the second phase (Day 9-14) the product (Protective Cream WO 3313) was applied twice daily and during the last phase (Day 15-21), the participants were asked to continue the product application procedure twice daily and to additionally wash the test area once daily with 5% SDS solution.
  •   Control area: During the first phase (Day 1–7) the control area was washed once daily with 5% SDS solution. During the second phase (Day 9-14) the area was not treated and during the last phase (Day 15-21) the participants were asked to wash the area once daily with 5% SDS solution.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Skin regeneration in the test area compared to control area after SDS-induced irritation. Test parameters: skin hydration (Corneometer), transepidermal water loss (Tewameter), skin redness (Chromameter) and skin roughness (PRIMOS measuring system). Measurements: 12-14 hours after product application on day 10, 12, and 15.

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Secondary Outcome

Skin protection against SDS-induced irritation in the test area compared to control area. Test parameters: skin hydration (Corneometer), transepidermal water loss (Tewameter), skin redness (Chromameter) and skin roughness(PRIMOS measuring system). Measurements: 5-6 hours after product application on day 17, 19, and 21.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2012/04/30
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Clinically healthy

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Exclusion Criteria

Skin diseases,
pregnancy

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Addresses

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    • 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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    • Derma Consult Concept GmbH
    • Mr.  Dr.  Boris  Nissen 
    • Hermann-Wandersleb-Ring 4
    • 53121  Bonn
    • 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
  •   2012/05/21
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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.