Prospective clinical trial, in which the test product (a cream containing 2% of Sertaconazol a known anti-mycotic ingredient) or the comparator product (cream without any active ingredient) are being dispatched randomly to the patients without that they or their physicians know which product they receive. Objective is to explore the anti-itch potential of the test product in atopic dermatitis as well as its safety and its local tolerability.

• Conditions: Atopic Dermatitis; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2012-003954-95-DE
• Lead Sponsor: Spirig Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-04
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- SCORAD (Severity SCORing of Atopic Dermatitis) =40 at inclusion
- Male or female (nonpregnant, nonlactating, using contra-ception)
- = 18 years or = 75.
- Atopic lesions: Arms. Additional: Legs, Neck (areas to be evaluated: arms)
- Chronic pruritus, persisting for at least 6 weeks before study start
- At the 2 days before Visit 1 Pruritus = 7 (VAS 0-10)
- At Visit 1 pruritus intensitiy = 3 (PGA questionnaire of the 5-point Likert Scale)
- Signed informed consent after patient information
- Agreement to discontinue for the duration of the trial the use of all current moisturizers and to replace them by a standard bland moisturizer given for all patients: Excipial Hy-drocrème
- Willing and able to participate in the trial as an outpatient and to comply with all trial requirements

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

-SCORAD at inclusion >40
-Evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g. cardiovascular, immunosuppressive, hematologic, hepatic, neurologic, renal, en-docrine, collagen-vascular, urogenital, gastro-intestinal abnormalities or diseases)
-Evidence of an active systemic or dermatological infection
-Evidence of immunosuppression or cancer
-Alcohol- or drug abuse as assessed by the investigator
-Participation in an other clinical study within a month of trial entry
-Dermatological abnormalities, diseases or conditions in the treatment or surrounding areas that might be exacerbated by treatment with 2% Sertaconazol Cream or impair trial assessments as assessed by the investigator
-Allergy or hypersensibility to any of the trial creams ingredients
-Treatments before and during the trial:
oTopical or systemic anti-histaminic drugs within 2 weeks before trial start
oSystemic corticosteroids or high-dosed topical corticosteroids within 4 weeks before trial entry.
olmmunomodulatory or cytotoxic treatments within 4 weeks before trial start.
oNaltrexon, antidepressants (like Paroxetin, Gabapentin, Pregabalin- if admitted because of their antipruritic effect) within 4 weeks before trial start.
oCiclosporin A and other Immunosuppressive drugs within 8 weeks before trial start,
oTopical calcineurin inhibitors, topical antibiotics, antiseptic baths and washes within 8 weeks before trial start.
-For female patients: pregnancy and lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Visit 1 (day 1), Visit 2 (day 14± 3), Visit 3 (day 28 ± 3), Visit 4 (day 42 ± 3);Main Objective: Main objective of the study is to explore the efficacy of a topical Sertaconazol cream 2% for prutitus in patients with atopic dermatitis in a non-acute, stable phase in comparision to pla-cebo. ;Secondary Objective: Safety, and tolerability of the treatment. <br>;Primary end point(s): Efficacy against pruritus, measured on the itch item of the 5-point Likert Scale in the PGA question-naire.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy<br>Intensitiy of pruritus determined by a visual analogue scale (VAS)<br>EASI <br>DLQI <br>PBI <br>PGA <br><br>Safety and tolerability<br>Recording of AE, SAE, ADR<br>Local tolarability<br>Systemic tolerability:<br>Blood chemistry (alkaline phosphatase, bilirubin, GOT, GPT, serum creatinine)<br>Vital signs<br>;Timepoint(s) of evaluation of this end point: PGA:Visit 1, Visit 2, Visit 3, Visit 4<br>SCORAD, EASI: Visit 1, Visit 3 and Visit 4<br>VAS: V1, V2, V3, V4<br>DLQI: V1, V3, V4<br>PBI: V1, V3<br>Recording of adverse events: V2, V3, V4<br>Blood chemisstriy: V1, V3<br>Vital signs: V1, V2, V3, V4<br>