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Completed

NCT Number: NCT00980135

Sinecort Pilot Efficacy Study

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

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Münster, North Rhine-Westphalia, 48155, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sinecort cream

Device

Application over 29 days

Hydrocortison cream

Drug

Application over 29 days

Untreated Skin

Other

Primary outcomes

  1. Efficacy rate versus comparator and untreated skin

    Time frame: After 29 days of twice daily applications

  2. Local side effects on the skin

    Time frame: 29 days

Secondary outcomes

  1. 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

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

    Time frame: after 29 days

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

    Time frame: after 29 days

  4. Erythema by means of chromametry at Visit 2 through Visit 6

    Time frame: after 29 days

  5. 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

  6. Incidence and severity of Adverse Event

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

  7. Vital signs

    Time frame: visit1 and 6 weeks after end of treatment

  8. Local side effects

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Acronym: Sinecort Pilot

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 18, 2009
Registry last updated
Apr 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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