search
Back to results

Promiseb Topical Cream for Cradle Cap

Primary Purpose

Cradle Cap, Infantile Seborrheic Dermatitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Promiseb Topical Cream
Bland emollient
Sponsored by
Promius Pharma, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cradle Cap focused on measuring Cradle Cap, Infantile seborrheic Dermatitis

Eligibility Criteria

30 Days - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Norwich Pediatric Group
  • Derm Research
  • UMDNJ
  • Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Promiseb Topical Cream

Bland emollient

Arm Description

Outcomes

Primary Outcome Measures

Subjects With Investigator Global Assessment (IGA) Success (IGA of 0 or 1) at End of Treatment (Day 7 or 14).
IGA scored on scale of 0 (clear) to 4 (severe).
Number of Participants With Excellent Overall Safety Score at 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).

Secondary Outcome Measures

Precent Reduction From Baseline for Scaling at End of Treatment.
Scaling score on a scale of 0 (none) to 4 (severe).
Percent Reduction From Baseline for Crusting at End of Treatment.
Crusting scored on a scale of 0 (none) to 4 (severe).
Percent Reduction From Baseline for Erythema at End of Treatment.
Erythema scored on scale of 0 (none) to 4 (severe).
Percent Reduction From Baseline for Oiliness at End of Treatment.
Oiliness scored on a scale of 0 (none) to 4 (severe).

Full Information

First Posted
September 28, 2010
Last Updated
January 23, 2017
Sponsor
Promius Pharma, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT01214434
Brief Title
Promiseb Topical Cream for Cradle Cap
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Promius Pharma, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cradle Cap, Infantile Seborrheic Dermatitis
Keywords
Cradle Cap, Infantile seborrheic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Promiseb Topical Cream
Arm Type
Experimental
Arm Title
Bland emollient
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Promiseb Topical Cream
Intervention Description
topical non steroidal cream, twice daily
Intervention Type
Other
Intervention Name(s)
Bland emollient
Intervention Description
Eucerin cream twice daily
Primary Outcome Measure Information:
Title
Subjects With Investigator Global Assessment (IGA) Success (IGA of 0 or 1) at End of Treatment (Day 7 or 14).
Description
IGA scored on scale of 0 (clear) to 4 (severe).
Time Frame
end of treatment (Day 7 or 14)
Title
Number of Participants With Excellent Overall Safety Score at End of Treatment.
Description
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).
Time Frame
End of treatment
Secondary Outcome Measure Information:
Title
Precent Reduction From Baseline for Scaling at End of Treatment.
Description
Scaling score on a scale of 0 (none) to 4 (severe).
Time Frame
From Baseline to end of treatment (Day 7 or 14)
Title
Percent Reduction From Baseline for Crusting at End of Treatment.
Description
Crusting scored on a scale of 0 (none) to 4 (severe).
Time Frame
From Baseline to end of treatment (Day 7 or 14)
Title
Percent Reduction From Baseline for Erythema at End of Treatment.
Description
Erythema scored on scale of 0 (none) to 4 (severe).
Time Frame
From Baseline to end of treatment (Day 7 or 14)
Title
Percent Reduction From Baseline for Oiliness at End of Treatment.
Description
Oiliness scored on a scale of 0 (none) to 4 (severe).
Time Frame
From Baseline to end of treatment (Day 7 or 14)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne M Fraser, PhD
Organizational Affiliation
Promius Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Norwich Pediatric Group
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Derm Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
UMDNJ
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Promiseb Topical Cream for Cradle Cap

We'll reach out to this number within 24 hrs