Non-interventional study to observe skin toxicities under a Docetaxel therapy in treatment of concomitant use of Lipikar Baume AP + ® (NIS LipiDoc)

Non-interventional study to observe skin toxicities under a Docetaxel therapy in treatment of concomitant use of Lipikar Baume AP + ® (NIS LipiDoc) - NIS LipiDoc

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00010725

Enrollment

500

Registered

2016-07-18

Start date

2016-06-30

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

L99.8 C61 C50 C16 C34

Interventions

Group 1: Observation of skin toxicity in oncological patients treated with Docetaxel and optional accompanying, supportive administration of Lipikar Baume AP + ® taking into account individual, tempor

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Presence of an indication for docetaxel - containing infusion therapy according to the monitoring plan - Age = 18 - Presentation of written consent of the patient data capture

Exclusion criteria

Exclusion criteria: - Pregnancy, lactation - Patients with a docetaxel - intolerance - Patients with an intolerance of Lipikar Baume AP + ® - application - Patients in 3rd- or xth-line therapy

Design outcomes

Primary

Measure	Time frame
Detection of cutaneous side effects according to Common Toxicity Criteria for Adverse Events (CTCAE, v.4.03) under guideline conform and indication according docetaxel therapy ORCAzwei	—

Secondary

Measure	Time frame
Observation of the efficacy of docetaxel ORCAzwei - therapy, taking into account the different indications and the Disease status (adjuvant, 1st-, 2nd-line) - Observation of tolerability and safety of docetaxel ORCAzwei - therapy - Observation quality of life (Quality of Life) by Patient Benefit Index Skin (PBI-K) under the optional accompanying, supportive use of Lipikar Baume AP + ® considering the individual, temporal use of concomitant therapy	—

Measure

Time frame

Observation of the efficacy of docetaxel ORCAzwei - therapy, taking into account the different indications and the Disease status (adjuvant, 1st-, 2nd-line) - Observation of tolerability and safety of docetaxel ORCAzwei - therapy - Observation quality of life (Quality of Life) by Patient Benefit Index Skin (PBI-K) under the optional accompanying, supportive use of Lipikar Baume AP + ® considering the individual, temporal use of concomitant therapy

—

Countries

Germany

Contacts

Public ContactAnna Merk

OnkoDataMed GmbH

anna.merk@onkodatamed.de03342 4268910

Outcome results

None listed

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