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A Study of E6005 in Japanese Patients With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT01179880
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Dermavant Sciences GmbH

Brief Summary:
The safety and pharmacokinetics of topical application with E6005 ointment compared to vehicle will be evaluated in Japanese male patients with atopic dermatitis. Additionally, the efficacy of topical application with E6005 ointment will be explored in Japanese male patients with atopic dermatitis.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: E6005 Drug: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of E6005 in Japanese Patients With Atopic Dermatitis
Study Start Date : September 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: E6005
Four Steps of Ointment Application: Step 1: 0.01% of E6005; Step 2: 0.03% of E6005; Step 3: 0.1% of E6005; Step 4: 0.2% of E6005.
Placebo Comparator: 2 Drug: Placebo
Matching placebo for each step



Primary Outcome Measures :
  1. Pharmacokinetic parameter Cmax will be calculated [ Time Frame: Until Day 13 ]
  2. Pharmacokinetic parameter tmax will be calculated [ Time Frame: Until Day 13 ]
  3. Pharmacokinetic parameter AUC(0-t) will be calculated [ Time Frame: Until Day 13 ]
  4. Pharmacokinetic parameter t1/2 will be calculated [ Time Frame: Until Day 13 ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria;

  • Japanese adult male patients with a confirmed diagnosis of atopic dermatitis according to "Guidelines for Management of Atopic Dermatitis" by the Japanese Dermatological Association.
  • Patients with evaluable typical eczema on the back (posterior trunk).
  • Patients whose age is equal to or more than 20 and less than 65 at the time of treatment and who can provide written informed consent.

Exclusion criteria;

  • Patients complicated with eye symptoms (e.g., cataract, retinal detachment), Kaposi varicelliform eruption, and molluscum contagiosum or impetigo contagiosa.
  • Patients who had or have a severe allergy such as anaphylactic shock, anaphylactic reaction and anaphylactoid reaction or allergy/hypersensitivity to E6005 or any of their excipients.
  • Patients who received any concomitant ethical drugs or any phototherapies within 14 days prior to Baseline. Subjects are allowed to use external steroids and tacrolimus ointment 8 or more days before Baseline and bland emollients free of medicinal properties (e.g., white petrolatum) throughout the study period.
  • Patients with any infection that required hospitalization or intravenous/oral treatment with antibiotic/antiviral/antifungal drug(s) within 28 days prior to Baseline.
  • Patients who had or have any malignancy, lymphoma, leukemia, or lymphoproliferative disorders, which dose not include skin cancers (e.g., squamous cell carcinoma or basal cell cancer) that were completely removed and have not metastasized for 5 years.

Information from the National Library of Medicine

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): NCT01179880


Locations
Japan
Fukuoka, Japan
Sponsors and Collaborators
Dermavant Sciences GmbH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dermavant Sciences GmbH
ClinicalTrials.gov Identifier: NCT01179880     History of Changes
Other Study ID Numbers: E6005-J081-101
First Posted: August 11, 2010    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

Keywords provided by Dermavant Sciences GmbH:
Dermatitis
Atopic

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