Promiseb Topical Cream for Cradle Cap

NCT ID: NCT01214434

Last Updated: 2017-03-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-06-30

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of Promiseb Topical Cream in cradle cap.

Detailed Description

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Conditions

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Cradle Cap Infantile Seborrheic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Promiseb Topical Cream

Group Type EXPERIMENTAL

Promiseb Topical Cream

Intervention Type DEVICE

topical non steroidal cream, twice daily

Bland emollient

Group Type SHAM_COMPARATOR

Bland emollient

Intervention Type OTHER

Eucerin cream twice daily

Interventions

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Promiseb Topical Cream

topical non steroidal cream, twice daily

Intervention Type DEVICE

Bland emollient

Eucerin cream twice daily

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of cradle cap
* Must be at least 30 days old
* Must be in good health as determined by investigator
* Naive to prior cradle cap therapy (may have used mineral, olive oils)

Exclusion Criteria

* Known food, topical product or medicinal allergies.
* Prior use of corticosteroids, antifungals or keratolytics for Cradle Cap
* Weighing less than 7 lbs
Minimum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Promius Pharma, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joanne M Fraser, PhD

Role: STUDY_DIRECTOR

Promius Pharma

Locations

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Norwich Pediatric Group

Norwich, Connecticut, United States

Site Status

Derm Research

Louisville, Kentucky, United States

Site Status

UMDNJ

Newark, New Jersey, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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PSC0903

Identifier Type: -

Identifier Source: org_study_id

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