Promiseb Topical Cream for Cradle Cap

NCT01214434 | Completed Phase 4 Results

• 1 other identifier: PSC0903
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Cradle Cap; Infantile Seborrheic Dermatitis

Keywords

Cradle Cap; Infantile seborrheic Dermatitis

Outcome Measures

Primary Outcomes (2)

• 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).

  end of treatment (Day 7 or 14)

• 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).

  End of treatment

Secondary Outcomes (4)

• Precent Reduction From Baseline for Scaling at End of Treatment.

  From Baseline to end of treatment (Day 7 or 14)

• Percent Reduction From Baseline for Crusting at End of Treatment.

  From Baseline to end of treatment (Day 7 or 14)

• Percent Reduction From Baseline for Erythema at End of Treatment.

  From Baseline to end of treatment (Day 7 or 14)

• Percent Reduction From Baseline for Oiliness at End of Treatment.

  From Baseline to end of treatment (Day 7 or 14)

Study Arms (2)

Promiseb Topical Cream

EXPERIMENTAL

Device: Promiseb Topical Cream

Bland emollient

SHAM COMPARATOR

Other: Bland emollient

Interventions

Promiseb Topical Cream DEVICE

topical non steroidal cream, twice daily

Promiseb Topical Cream

Bland emollient OTHER

Eucerin cream twice daily

Bland emollient

Eligibility Criteria

• Age: 30 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Promius Pharma, LLC: lead

Study Sites (4)

Norwich Pediatric Group

Norwich, Connecticut, 06360, United States

Location

Derm Research

Louisville, Kentucky, 40217, United States

Location

UMDNJ

Newark, New Jersey, 07101, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Dermatitis, Seborrheic; Complement component 5 deficiency

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Limitations and Caveats

Small number of subjects enrolled and analyzed.

Results Point of Contact

• Title: Medical Information Center
• Organization: Promius Pharma, LLC

product-complaints@promiuspharma.com

888 966-8766

Study Officials

• Joanne M Fraser, PhD

  Promius Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: October 5, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 7, 2017
• Results First Posted: November 20, 2013

Record last verified: 2017-01

Locations

US (4)