Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)
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ClinicalTrials.gov Identifier: NCT02001181 |
Recruitment Status :
Completed
First Posted : December 4, 2013
Results First Posted : October 15, 2015
Last Update Posted : October 15, 2015
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Dermatitis, Atopic |
Interventions |
Drug: Tofacitinib ointment 20mg/g Drug: Placebo ointment (Vehicle) |
Enrollment | 69 |
Participant Flow
Recruitment Details | Eligibility included male or female participants, 18 to 60 years of age (inclusive), who had a clinical diagnosis of atopic dermatitis for at least 6 months and clinically stable for >=1 month. |
Pre-assignment Details | During the screening/washout period, participants' current therapies (topical, systemic, and phototherapy) for atopic dermatitis were discontinued and only non-medicated study emollient, sunscreen topical products, and specific shampoos (for atopic dermatitis on hair-bearing scalp) were permitted. |
Arm/Group Title | Tofacitinib 20 mg/g BID | Vehicle BID |
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Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks. | Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks. |
Period Title: Overall Study | ||
Started | 35 | 34 |
Completed | 34 | 31 |
Not Completed | 1 | 3 |
Reason Not Completed | ||
Adverse Event | 0 | 2 |
Lost to Follow-up | 1 | 0 |
Withdrawal by Subject | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Tofacitinib 20 mg/g BID | Vehicle BID | Total | |
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Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks. | Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 35 | 34 | 69 | |
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The full analysis set included all participants who were randomized and received at least 1 dose of study drug.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 35 participants | 34 participants | 69 participants | |
32.4 (9.8) | 30.4 (10.4) | 31.4 (10.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 35 participants | 34 participants | 69 participants | |
Female |
19 54.3%
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18 52.9%
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37 53.6%
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Male |
16 45.7%
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16 47.1%
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32 46.4%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: | Pfizer ClinicalTrials.gov Call Center |
Organization: | Pfizer, Inc. |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT02001181 |
Other Study ID Numbers: |
A3921214 |
First Submitted: | November 27, 2013 |
First Posted: | December 4, 2013 |
Results First Submitted: | September 16, 2015 |
Results First Posted: | October 15, 2015 |
Last Update Posted: | October 15, 2015 |