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Promiseb Topical Cream for Cradle Cap

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ClinicalTrials.gov Identifier: NCT01214434
Recruitment Status : Completed
First Posted : October 5, 2010
Results First Posted : November 20, 2013
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Promius Pharma, LLC

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

Condition or disease Intervention/treatment Phase
Cradle Cap Infantile Seborrheic Dermatitis Device: Promiseb Topical Cream Other: Bland emollient Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011


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




Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214434


Locations
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United States, Connecticut
Norwich Pediatric Group
Norwich, Connecticut, United States, 06360
United States, Kentucky
Derm Research
Louisville, Kentucky, United States, 40217
United States, New Jersey
UMDNJ
Newark, New Jersey, United States, 07101
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Promius Pharma, LLC
Investigators
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Study Director: Joanne M Fraser, PhD Promius Pharma

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Responsible Party: Promius Pharma, LLC
ClinicalTrials.gov Identifier: NCT01214434     History of Changes
Other Study ID Numbers: PSC0903
First Posted: October 5, 2010    Key Record Dates
Results First Posted: November 20, 2013
Last Update Posted: March 7, 2017
Last Verified: January 2017

Keywords provided by Promius Pharma, LLC:
Cradle Cap
Infantile seborrheic Dermatitis

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Seborrheic
Immunologic Deficiency Syndromes
Skin Diseases
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous
Immune System Diseases
Emollients
Dermatologic Agents