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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00009504

Enrollment

Registered

2015-10-16

Start date

2013-03-12

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin irritation in the outer anogenital region

Interventions

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

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Women with skin irritation in the outer anogenital area

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Countries

Germany

Contacts

Public ContactVolkmar Küppers

Praxis Dr. Küppers

praxis@dysplasie-praxis.de0211-32 83 85

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026