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Completed

NCT Number: NCT01214434

Promiseb Topical Cream for Cradle Cap

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

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Key information

Conditions

Cradle Cap Complement component 5 deficiency Dermatitis Dermatitis, Seborrheic Infantile Seborrheic Dermatitis Sebaceous Gland Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

30 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Norwich Pediatric Group, Norwich, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Promiseb Topical Cream

Device

topical non steroidal cream, twice daily

Bland emollient

Other

Eucerin cream twice daily

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Promius Pharma, LLC

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 5, 2010
Registry last updated
Mar 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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