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Sinecort Pilot Efficacy Study (Sinecort Pilot)

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Sinecort cream

Hydrocortison cream

Untreated skin

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Sinecort, Hydrocortison, Mild atopic dermatitis, Efficacy, safety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female Caucasians aged between 18 and 65 years
Patients with mild AD presenting a scoring AD (SCORAD) rating between 3-25
Skin type I - IV according to Fitzpatrick
Acute AD symptoms on each assessment areas (local SCORAD >/=3 and <= 12)
Acute symptom of pruritus at Baseline

Exclusion Criteria:

Any other skin disease at the test area that would interfere the clinical assessment in the opinion of the investigator
Moles, tattoos, strong pigmentation, or scars at the test area that would interfere the clinical assessment
Regular intake of antiphlogistic drugs (for example, NSAIDs)
Any condition or treatment which might influence the trial (e.g. any treatment with topical antibiotics, antifungals, or corticoids) within 14 days prior to screening as well as during the trial (exception: topical treatment of AD lesions other than the test areas (for example, face) with low potency steroids restricted to small areas)
UV-therapy or the use of solarium within 30 days before screening as well as during the trial
Any alternative treatment of AD (e.g. acupuncture, kinesiology, and homoeopathy) within 30 days before screening as well as during the trial

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Outcomes

Primary Outcome Measures

Efficacy rate versus comparator and untreated skin

Local side effects on the skin

Secondary Outcome Measures

Local SCORAD as clinical assessment by means of the intensity items of the SCORAD index) at Visit 2 through Visit 6

Transepidermal water loss (TEWL) as a measure for skin barrier function at Visit 2 through Visit 6

Skin hydration by means of corneometry at visit 2 through visit 6

Erythema by means of chromametry at Visit 2 through Visit 6

Intensity of pruritus at each day of the dosing period (day 1- day 29) as reported in the patients diary and at Visit 2 through Vist 6 by means of visual analogue scale (VAS)

Incidence and severity of Adverse Event

Vital signs

Local side effects

Full Information

NCT ID

NCT00980135

First Posted

September 16, 2009

Last Updated

March 31, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00980135

Brief Title

Sinecort Pilot Efficacy Study

Acronym

Sinecort Pilot

Official Title

An Investigator-blind, Randomized, Monocentre, 3-arm, Active Controlled Pilot Trial to Explore the Efficacy and Safety of a New Topical Medical Device in Patients With Mild Atopic Dermatitis in an Intra-individual Comparison With a Standard Therapy (1% Hydrocortisone Cream) and Untreated Skin.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The study shall prove whether treatment of atopic dermatitis is equally effective with Sinecort cream as compared to standard therapy (Hydrocortisone cream).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

Sinecort, Hydrocortison, Mild atopic dermatitis, Efficacy, safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Experimental

Arm Title

Arm 3

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

Sinecort cream

Intervention Description

Application over 29 days

Intervention Type

Drug

Intervention Name(s)

Hydrocortison cream

Intervention Description

Application over 29 days

Intervention Type

Other

Intervention Name(s)

Untreated skin

Primary Outcome Measure Information:

Title

Efficacy rate versus comparator and untreated skin

Time Frame

After 29 days of twice daily applications

Title

Local side effects on the skin

Time Frame

29 days

Secondary Outcome Measure Information:

Title

Local SCORAD as clinical assessment by means of the intensity items of the SCORAD index) at Visit 2 through Visit 6

Time Frame

after 29 days

Title

Transepidermal water loss (TEWL) as a measure for skin barrier function at Visit 2 through Visit 6

Time Frame

after 29 days

Title

Skin hydration by means of corneometry at visit 2 through visit 6

Time Frame

after 29 days

Title

Erythema by means of chromametry at Visit 2 through Visit 6

Time Frame

after 29 days

Title

Intensity of pruritus at each day of the dosing period (day 1- day 29) as reported in the patients diary and at Visit 2 through Vist 6 by means of visual analogue scale (VAS)

Time Frame

after 29 days

Title

Incidence and severity of Adverse Event

Time Frame

visit 2 (start of dosing period) till 6 weeks after end of treatment

Title

Vital signs

Time Frame

visit1 and 6 weeks after end of treatment

Title

Local side effects

Time Frame

visit 2 (start of dosing period) till 6 weeks after end of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female Caucasians aged between 18 and 65 years Patients with mild AD presenting a scoring AD (SCORAD) rating between 3-25 Skin type I - IV according to Fitzpatrick Acute AD symptoms on each assessment areas (local SCORAD >/=3 and <= 12) Acute symptom of pruritus at Baseline Exclusion Criteria: Any other skin disease at the test area that would interfere the clinical assessment in the opinion of the investigator Moles, tattoos, strong pigmentation, or scars at the test area that would interfere the clinical assessment Regular intake of antiphlogistic drugs (for example, NSAIDs) Any condition or treatment which might influence the trial (e.g. any treatment with topical antibiotics, antifungals, or corticoids) within 14 days prior to screening as well as during the trial (exception: topical treatment of AD lesions other than the test areas (for example, face) with low potency steroids restricted to small areas) UV-therapy or the use of solarium within 30 days before screening as well as during the trial Any alternative treatment of AD (e.g. acupuncture, kinesiology, and homoeopathy) within 30 days before screening as well as during the trial

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Münster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48155

Country

Germany

12. IPD Sharing Statement

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Sinecort Pilot Efficacy Study

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