Sertaconazole 2% Cream to Improve Symptoms Associated With Atopic Dermatitis

S

Spirig Pharma

Status and phase

Completed
Phase 2

Conditions

Skin Alterations Associated With Atopic Dermatitis

Treatments

Drug: Sertaconazole 2% cream
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01792713
E550-PRU-2012
2012-003954-95 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

70 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

70 participants in 2 patient groups, including a placebo group

Sertaconazole 2% cream
Active Comparator group
Description:
2x daily treatment with Sertaconazole 2% cream for 4 weeks, 2 weeks follow-up
Treatment:
Drug: Sertaconazole 2% cream
Placebo Arm
Placebo Comparator group
Description:
2x daily treatment with Placebo cream for 4 weeks, 2 weeks follow-up
Treatment:
Drug: Placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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