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CompletedNCT01792713Updated May 20, 2015

Sertaconazole 2% Cream to Improve Symptoms Associated With Atopic Dermatitis

A Phase 2 interventional study of Sertaconazole 2% cream and Placebo in Skin Alterations Associated With Atopic Dermatitis, sponsored by Spirig Pharma Ltd.. Completed at 2 sites in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-05-20.

Sponsored by Spirig Pharma Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Skin Alterations Associated With Atopic Dermatitis

Keywords

  • Skin alterations
  • Atopic Dermatitis
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 70 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Spirig Pharma Ltd. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    Sertaconazole 2% cream

    2x daily treatment with Sertaconazole 2% cream for 4 weeks, 2 weeks follow-up

    Drug: Sertaconazole 2% cream

  • Placebo comparator
    Placebo Arm

    2x daily treatment with Placebo cream for 4 weeks, 2 weeks follow-up

    Drug: Placebo

Interventions

  • DrugSertaconazole 2% cream
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Change in Patient Global Assessment (PGA)

    Time frame: day 1, day 28

Secondary outcomes

  1. Change in Eczema Area and Severity Index (EASI)

    Time frame: day 1, day 28

  2. Change in Dermatology Life Quality Index (DLQI)

    Time frame: d1, d28

  3. Change in Patient Benefit Index (PBI)

    Time frame: day 1, day 28

Other outcomes

  1. Change in Transepidermal water loss (TEWL)

    Time frame: d1, d14, d28, d42

07

Study locations

2 sites
  • Universitätsmedizin Charité Berlin, Abteilung für Dermatologie und Allergologie
    Berlin, 10117, Germany
  • Universitätsklinikum Münster, Klinik für Hautkrankheiten
    Münster, 48149, Germany
08

References and documents

Publications

  • Stander S, Metz M, Ramos F MH, Maurer M, Schoepke N, Tsianakas A, Zeidler C, Luger TA. Anti-pruritic Effect of Sertaconazole 2% Cream in Atopic Dermatitis Subjects: A Prospective, Randomized, Double-blind, Vehicle-controlled, Multi-centre Clinical Trial of Efficacy, Safety and Local Tolerability. Acta Derm Venereol. 2016 Aug 23;96(6):792-6. doi: 10.2340/00015555-2268. PubMed 26527564 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01792713
Lead sponsor
Spirig Pharma Ltd.
Responsible party
Sponsor
First posted
Feb 15, 2013
Start date
Feb 2013
Primary completion
Sep 2013
Completion
Feb 2014
Last update
May 20, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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