Sertaconazole 2% Cream to Improve Symptoms Associated With Atopic Dermatitis

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

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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