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A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome

A First-In-human Study to Evaluate Safety and Tolerability of Topical BPR277 in Healthy Volunteers, and Proof of Concept (PoC) Studies to Evaluate the Safety, Tolerability, and Efficacy of Topical BPR277 in Patients With Atopic Dermatitis and Netherton Syndrome

NCT01428297•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The study is divided in 3 parts, starting with the safety assessment of BPR277 ointment in Healthy volunteers (Part 1). If found to be well tolerated in Part 1, BPR277 ointment will be assessed in two different patients groups to evaluate safety and efficacy in atopic dermatitis (Part 2) and in Netherton syndrome (Part 3).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Part 1 Healthy volunteers
•Healthy male and female subjects of non childbearing potential, 18 to 65 years of age inclusive and in good health
•Part 2 Patients with atopic dermatitis:
•Male and female subjects, 18 to 65 years of age inclusive and having passed screening examinations
•Presence of atopic dermatitis confirmed by Itchy skin condition in the past 12 months (must have) Plus three or more of the following:
•1. History of involvement of the skin creases
•2. Personal history of asthma or hay fever
•3. History of generally dry skin in the past year
•4. Onset before age of 2 years
•5. Visible flexural dermatitis
+5 more criteria

Exclusion Criteria

•Part 1 Healthy volunteers :
•History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
•Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing.
•Part 2 Patients with atopic dermatitis:
•History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction.
•History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks to study start (screening), including tanning and sun beds.
•Pregnant or nursing (lactating) women.
•Women of child-bearing potential must use highly effective contraception (as further defined in study protocol)
•Use of topical prescription treatment for eczema within 1 week prior to initial dosing of topical corticosteroids (TCS).
•Recent previous treatment with systemic treatment including phototherapy. A washout period will be required for such patients to be eligible to participate in the trial.
+7 more criteria

Locations (4)

Novartis Investigative Site

New Haven, Connecticut, United States

Novartis Investigative Site

St Louis, Missouri, United States

Novartis Investigative Site

Fargo, North Dakota, United States

Novartis Investigative Site

Utrecht, The Netherlands, Netherlands

Key Dates

Start Date

May 1, 2011

Primary Completion Date

February 1, 2014

Completion Date

February 1, 2014

Last Updated

December 8, 2020

Enrollment

ACTUAL participants

Conditions

Healthy VolunteersAtopic DermatitisNetherton Syndrome

Interventions

BPR277 ointment (controlled application)

DRUG

Placebo (Vehicle)

DRUG

BPR277 ointment

DRUG

Placebo (Vehicle)

DRUG

BPR277

DRUG

Placebo (Vehicle)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome

Inclusion Criteria

Exclusion Criteria

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