Sertaconazole 2% Cream to Improve Symptoms Associated With Atopic Dermatitis

Randomisierte, Doppelblinde, Plazebo-kontrollierte Prüfung Zum Nachweis Der Wirksamkeit Und Der Lokalen Verträglichkeit Einer 2%Igen Sertaconazol-Crème Bei Patienten Mit Atopischer Dermatitis (Abridged)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01792713

Enrollment

Registered

2013-02-15

Start date

2013-02-28

Completion date

2014-02-28

Last updated

2015-05-20

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

Conditions

Skin Alterations Associated With Atopic Dermatitis

Keywords

Skin alterations, Atopic Dermatitis

Brief summary

Investigation aimed to explore the efficacy of a topical Sertaconazole cream 2% in patients with skin alterations associated with atopic dermatitis

Interventions

DRUGSertaconazole 2% cream

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Informed consent * Atopic Dermatitis Patients with SCORing Atopic Dermatitis (SCORAD) ≤ 40 * Atopic lesion localisation: arms; additional legs, neck

Exclusion criteria

* SCORAD \> 40 * Unstable, uncontrolled medical status (e.g. active systemic or topical infection) * Active immunosuppression or cancer * Narcotics- or Alcohol abuse * Participation in another clinical trial until one month prior inclusion * Known allergies against an ingredient of the investigational medicinal product * Different periods of grace for certain pre-treatments, e.g. topical corticosteroids, immune modulating drugs * Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Change in Patient Global Assessment (PGA)	day 1, day 28

Secondary

Measure	Time frame
Change in Eczema Area and Severity Index (EASI)	day 1, day 28
Change in Dermatology Life Quality Index (DLQI)	d1, d28
Change in Patient Benefit Index (PBI)	day 1, day 28

Other

Measure	Time frame
Change in Transepidermal water loss (TEWL)	d1, d14, d28, d42

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026