Promiseb Topical Cream for Cradle Cap

January 23, 2017 updated by: Promius Pharma, LLC

A Double Blind, Placebo-Controlled, Pilot Study to Estimate the Efficacy and Tolerability of Twice Daily Promiseb Topical Cream in Pediatric Subjects With Cradle Cap (Seborrheic Dermatitis)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Norwich Pediatric Group
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Derm Research
    • New Jersey
      • Newark, New Jersey, United States, 07101
        • UMDNJ
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Promiseb Topical Cream
Device: Promiseb Topical Cream
topical non steroidal cream, twice daily
Sham Comparator: Bland emollient
Other: Bland emollient
Eucerin cream twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects With Investigator Global Assessment (IGA) Success (IGA of 0 or 1) at End of Treatment (Day 7 or 14).
Time Frame: end of treatment (Day 7 or 14)
IGA scored on scale of 0 (clear) to 4 (severe).
end of treatment (Day 7 or 14)
Number of Participants With Excellent Overall Safety Score at End of Treatment.
Time Frame: End of treatment
The investigator will assess tolerance at Day 7 and Day 14 using an overall safety score of 0 to 3 defined as; Grade 0-No signs of irritation (excellent); Grade 1-Slight signs of irritation which resolved (Good); Grade 2-Clear signs of irritation (Fair); Grade 3-Patient discontinued due to irritation(Poor).
End of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Precent Reduction From Baseline for Scaling at End of Treatment.
Time Frame: From Baseline to end of treatment (Day 7 or 14)
Scaling score on a scale of 0 (none) to 4 (severe).
From Baseline to end of treatment (Day 7 or 14)
Percent Reduction From Baseline for Crusting at End of Treatment.
Time Frame: From Baseline to end of treatment (Day 7 or 14)
Crusting scored on a scale of 0 (none) to 4 (severe).
From Baseline to end of treatment (Day 7 or 14)
Percent Reduction From Baseline for Erythema at End of Treatment.
Time Frame: From Baseline to end of treatment (Day 7 or 14)
Erythema scored on scale of 0 (none) to 4 (severe).
From Baseline to end of treatment (Day 7 or 14)
Percent Reduction From Baseline for Oiliness at End of Treatment.
Time Frame: From Baseline to end of treatment (Day 7 or 14)
Oiliness scored on a scale of 0 (none) to 4 (severe).
From Baseline to end of treatment (Day 7 or 14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Promius Pharma, LLC

Investigators

  • Study Director: Joanne M Fraser, PhD, Promius Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

September 28, 2010

First Submitted That Met QC Criteria

October 1, 2010

First Posted (Estimate)

October 5, 2010

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSC0903

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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