Efficacy/Safety Study to Explore a New Topical Formulation in Atopic Dermatitis (Phoenix)
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ClinicalTrials.gov Identifier: NCT01691209 |
Recruitment Status
:
Withdrawn
First Posted
: September 24, 2012
Last Update Posted
: August 13, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dermatitis, Atopic | Device: Phoenix (BAY81-2996) Drug: 1% Hydrocortison cream | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | An Investigator-blinded, Randomized, Monocentre, 3-arm, Active Controlled Pilot Trial to Explore the Efficacy and Safety of a Topical Medical Device in Patients With Mild to Moderate Atopic Dermatitis in an Intra-individual Comparison With a Standard Therapy (1% Hydrocortisone Cream) and Untreated Skin |
Study Start Date : | October 2013 |
Estimated Primary Completion Date : | April 2014 |
Estimated Study Completion Date : | June 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Phoenix
Application over 29 days twice daily
|
Device: Phoenix (BAY81-2996)
Topical formulation applied to the skin
|
Active Comparator: Hydrocortison
Application over 29 days twice daily
|
Drug: 1% Hydrocortison cream
1% Hydrocortison cream applied to the skin
|
No Intervention: Untreated skin
Participants will be observed over 29 days without study treatment
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- Number of participants with abnormal vital signs [ Time Frame: Up to 10 weeks ]Vital signs consist of blood pressure, heart rate and body temperature.
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 10 weeks ]
- Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index [ Time Frame: Up to 29 days ]
- Transepidermal water loss (TEWL) as a measure for skin barrier function [ Time Frame: Up to 29 days ]
- Skin hydration by means of corneometry [ Time Frame: Up to 29 days ]
- Erythema by means of chromametry [ Time Frame: Up to 29 days ]
- Intensity of pruritus by means of visual analogue scale (VAS) [ Time Frame: Up to 29 days ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691209
Germany | |
Münster, Nordrhein-Westfalen, Germany, 48155 |
Study Director: | Bayer Study Director | Bayer |
Additional Information:
Responsible Party: | Head Medical Affairs, Bayer HealthCare AG, Consumer Care |
ClinicalTrials.gov Identifier: | NCT01691209 History of Changes |
Other Study ID Numbers: |
16200 2012-001504-38 ( EudraCT Number ) |
First Posted: | September 24, 2012 Key Record Dates |
Last Update Posted: | August 13, 2013 |
Last Verified: | August 2013 |
Keywords provided by Bayer:
Phoenix Hydrocortison mild atopic dermatitis efficacy safety |
Additional relevant MeSH terms:
Dermatitis Dermatitis, Atopic Eczema Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate Cortisol succinate Hydrocortisone Anti-Inflammatory Agents |