Clinical study to assess efficacy and tolerability of Protective Balm WO 3396 in the anogenital area of women suffering from skin irritatio
Not Applicable
- Conditions
- Skin irritation in the outer anogenital region
- Registration Number
- DRKS00009504
- Lead Sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 43
Inclusion Criteria
Women with skin irritation in the outer anogenital area
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method The quality and frequency of adverse events observed during the 4-week treatment.<br><br>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).<br><br>Overall rating of efficacy on day 28 (physician/subjects).<br><br>Overall rating of tolerability on day 28 (physician/subjects).<br><br>Assessment of product properties on day 28 (subject questionnaire).