Promiseb Topical Cream for Cradle Cap

Promius Pharma

Status and phase: Completed; Phase 4

Conditions: Infantile Seborrheic Dermatitis; Cradle Cap

Treatments: Device: Promiseb Topical Cream; Other: Bland emollient

Study type: Interventional

Funder types: Industry

Identifiers

NCT01214434

PSC0903

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 30+ days old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups

Promiseb Topical Cream

Experimental group

Treatment:

Device: Promiseb Topical Cream

Bland emollient

Sham Comparator group

Treatment:

Other: Bland emollient