Efficacy/Safety Study to Explore a New Topical Formulation in Atopic Dermatitis

NCT01691209 | Withdrawn

• 2 other identifiers: 162002012-001504-38
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The study shall explore whether treatment of atopic dermatitis is equally effective with Phoenix medical device as compared to standard therapy (Hydrocortisone cream).

Conditions

Dermatitis, Atopic

Keywords

Phoenix; Hydrocortison; mild atopic dermatitis; efficacy; safety

Outcome Measures

Secondary Outcomes (2)

• Number of participants with abnormal vital signs

  Up to 10 weeks

• Number of participants with adverse events as a measure of safety and tolerability

  Up to 10 weeks

Other Outcomes (5)

• Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index

  Up to 29 days

• Transepidermal water loss (TEWL) as a measure for skin barrier function

  Up to 29 days

• Skin hydration by means of corneometry

  Up to 29 days

Study Arms (3)

Phoenix

EXPERIMENTAL

Application over 29 days twice daily

Device: Phoenix (BAY81-2996)

Hydrocortison

ACTIVE COMPARATOR

Application over 29 days twice daily

Drug: 1% Hydrocortison cream

Untreated skin

NO INTERVENTION

Participants will be observed over 29 days without study treatment

Interventions

Phoenix (BAY81-2996) DEVICE

Topical formulation applied to the skin

Phoenix

1% Hydrocortison cream DRUG

1% Hydrocortison cream applied to the skin

Hydrocortison

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female Caucasians aged between 18 and 60 years
• Patients with mild atopic dermatitis (AD) presenting a scoring AD (SCORAD) rating below 50
• Skin type I - IV according to Fitzpatrick
• Acute AD symptoms on each assessment areas (local SCORAD ≥ 3 and \<= 12) at Baseline
• Acute symptom of pruritus at Baseline

You may not qualify if:

• Any other skin disease at the test area that would interfere with the clinical assessment in the opinion of the investigator
• Moles, tattoos, strong pigmentation, or scars at the test area that would interfere with the clinical assessment
• Regular intake of antiphlogistic drugs (for example nonsteroidal anti-inflammatory drugs \[NSAIDs\])
• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Münster, North Rhine-Westphalia, 48155, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

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

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 20, 2012
• First Posted: September 24, 2012
• Study Start: October 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 13, 2013

Record last verified: 2013-08

Locations

DE (1)