Non-interventional study regarding the combined topical treatment of acne vulgaris with Dipalen® 1 mg/g cream or gel plus Nadixa® 10 mg/g cream

Non-interventional study regarding the combined topical treatment of acne vulgaris with Dipalen® 1 mg/g cream or gel plus Nadixa® 10 mg/g cream - NIS-057

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00014741

Enrollment

480

Registered

2018-05-08

Start date

2018-05-15

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

L70.0

Interventions

Group 1: There is only one treatment arm. The parallel topical Treatment with Dipalen cream or gel (active substance: Adapalen) plus Nadixa cream (active substance: Nadifloxacin) will be documented. T

Eligibility

Sex/Gender

All

Age

14 Years to No maximum

Inclusion criteria

Inclusion criteria: at least 14 years of Age, acne vulgaris of the face, prescription of Dipalen plus Nadixa

Exclusion criteria

Exclusion criteria: younger than 14 years of Age, systemic pretreatment of acne, combined pretreatment of acne with adapalen plus nadifloxacin

Design outcomes

Primary

Measure	Time frame
•Severity grading of facial acne using the revised Leeds Acne Grading System (grade 1 to 12) [O’Brien et al. 1998]) •Assessment of the typical symptoms of facial acne [according to Gollnick & Orfanos 1993] •Global assessment of efficacy by the physician and the patient •Quality of life (QoL) assessment performed using the German version of Dermatology Life Quality Index (DLQI) or the children’s version thereof (CDLQI), as appropriate •Global assessment of tolerability by the physician and the patient •Documentation of adverse drug reactions •Documentation of premature discontinuation •Previous treatments (description) •Actual treatment regimen (description) •Further treatment (description)	—

Measure

Time frame

•Severity grading of facial acne using the revised Leeds Acne Grading System (grade 1 to 12) [O’Brien et al. 1998]) •Assessment of the typical symptoms of facial acne [according to Gollnick & Orfanos 1993] •Global assessment of efficacy by the physician and the patient •Quality of life (QoL) assessment performed using the German version of Dermatology Life Quality Index (DLQI) or the children’s version thereof (CDLQI), as appropriate •Global assessment of tolerability by the physician and the patient •Documentation of adverse drug reactions •Documentation of premature discontinuation •Previous treatments (description) •Actual treatment regimen (description) •Further treatment (description)

—

Secondary

Measure	Time frame
see Primary endpoint. In this noninterventional study there are no Primary or secondary endpoints. All variables will be evaluated descriptively. No hypothesis will be tested, no comparison of different populations will be done.	—

Countries

Germany

Contacts

Public ContactGünter Hermann

Dr. R. Pfleger GmbH

pharmacovigilance@dr-pfleger.de0951/6043-0

Outcome results

None listed

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