NCT01792713

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

7 months

First QC Date

February 13, 2013

Last Update Submit

May 19, 2015

Conditions

Skin Alterations Associated With Atopic Dermatitis

Keywords

Skin alterationsAtopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Change in Patient Global Assessment (PGA)

    day 1, day 28

Secondary Outcomes (3)

  • 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 Outcomes (1)

  • Change in Transepidermal water loss (TEWL)

    d1, d14, d28, d42

Study Arms (2)

Sertaconazole 2% cream

ACTIVE COMPARATOR

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

Drug: Sertaconazole 2% cream

Placebo Arm

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Sertaconazole 2% creamDRUG
Sertaconazole 2% cream
PlaceboDRUG
Placebo Arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • SCORAD \> 40
  • Unstable, uncontrolled medical status (e.g. active systemic or topical infection)
  • Active immunosuppression or cancer
  • Narcotics- or Alcohol abuse
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätsmedizin Charité Berlin, Abteilung für Dermatologie und Allergologie

Berlin, 10117, Germany

Location

Universitätsklinikum Münster, Klinik für Hautkrankheiten

Münster, 48149, Germany

Location

Related Publications (1)

  • 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.

    PMID: 26527564DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

sertaconazole

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2013

First Posted

February 15, 2013

Study Start

February 1, 2013

Primary Completion

September 1, 2013

Study Completion

February 1, 2014

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

DE(2)