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Promiseb Topical Cream for Cradle Cap

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)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01214434
Enrollment
42
Registered
2010-10-05
Start date
2010-03-31
Completion date
2011-06-30
Last updated
2017-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cradle Cap, Infantile Seborrheic Dermatitis

Keywords

Cradle Cap, Infantile seborrheic Dermatitis

Brief summary

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

Interventions

DEVICEPromiseb Topical Cream

topical non steroidal cream, twice daily

OTHERBland emollient

Eucerin cream twice daily

Sponsors

Promius Pharma, LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Days to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Subjects With Investigator Global Assessment (IGA) Success (IGA of 0 or 1) at End of Treatment (Day 7 or 14).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.End of treatmentThe 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

MeasureTime frameDescription
Precent Reduction From Baseline for Scaling at End of Treatment.From Baseline to end of treatment (Day 7 or 14)Scaling score on a scale of 0 (none) to 4 (severe).
Percent Reduction From Baseline for Crusting at End of Treatment.From Baseline to end of treatment (Day 7 or 14)Crusting scored on a scale of 0 (none) to 4 (severe).
Percent Reduction From Baseline for Erythema at End of Treatment.From Baseline to end of treatment (Day 7 or 14)Erythema scored on scale of 0 (none) to 4 (severe).
Percent Reduction From Baseline for Oiliness at End of Treatment.From Baseline to end of treatment (Day 7 or 14)Oiliness scored on a scale of 0 (none) to 4 (severe).

Countries

United States

Participant flow

Participants by arm

ArmCount
Bland Emollient
Bland emollient : Eucerin cream twice daily
15
Promiseb Topical Cream
Promiseb Topical Cream : topical non steroidal cream, twice daily
27
Total42

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up22
Overall StudySite error10
Overall StudyWithdrawal by Subject10

Baseline characteristics

CharacteristicPromiseb Topical CreamBland EmollientTotal
Age, Categorical
<=18 years
27 Participants15 Participants42 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous0.8 years
STANDARD_DEVIATION 1.6
1.5 years
STANDARD_DEVIATION 3.5
1.0 years
STANDARD_DEVIATION 2.3
Region of Enrollment
United States
27 participants15 participants42 participants
Sex: Female, Male
Female
11 Participants9 Participants20 Participants
Sex: Female, Male
Male
16 Participants6 Participants22 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
1 / 120 / 25
serious
Total, serious adverse events
0 / 120 / 25

Outcome results

Primary

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).

Time frame: End of treatment

Population: All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.

ArmMeasureValue (NUMBER)
Bland EmollientNumber of Participants With Excellent Overall Safety Score at End of Treatment.12 participants
Promiseb Topical CreamNumber of Participants With Excellent Overall Safety Score at End of Treatment.25 participants
Primary

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).

Time frame: end of treatment (Day 7 or 14)

Population: All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.

ArmMeasureValue (NUMBER)
Bland EmollientSubjects With Investigator Global Assessment (IGA) Success (IGA of 0 or 1) at End of Treatment (Day 7 or 14).91.7 percentage of participants
Promiseb Topical CreamSubjects With Investigator Global Assessment (IGA) Success (IGA of 0 or 1) at End of Treatment (Day 7 or 14).96 percentage of participants
p-value: >0.05Chi-squared
Secondary

Percent Reduction From Baseline for Crusting at End of Treatment.

Crusting scored on a scale of 0 (none) to 4 (severe).

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

Population: All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.

ArmMeasureValue (MEAN)Dispersion
Bland EmollientPercent Reduction From Baseline for Crusting at End of Treatment.85 percent reduction from baselineStandard Deviation 22
Promiseb Topical CreamPercent Reduction From Baseline for Crusting at End of Treatment.78 percent reduction from baselineStandard Deviation 48
p-value: =0.6t-test, 2 sided
Secondary

Percent Reduction From Baseline for Erythema at End of Treatment.

Erythema scored on scale of 0 (none) to 4 (severe).

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

Population: All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.

ArmMeasureValue (MEAN)Dispersion
Bland EmollientPercent Reduction From Baseline for Erythema at End of Treatment.74 percent reduction from baselineStandard Deviation 43
Promiseb Topical CreamPercent Reduction From Baseline for Erythema at End of Treatment.89 percent reduction from baselineStandard Deviation 26
p-value: =0.24t-test, 2 sided
Secondary

Percent Reduction From Baseline for Oiliness at End of Treatment.

Oiliness scored on a scale of 0 (none) to 4 (severe).

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

Population: All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.

ArmMeasureValue (MEAN)Dispersion
Bland EmollientPercent Reduction From Baseline for Oiliness at End of Treatment.88 percent reduction from baselineStandard Deviation 23
Promiseb Topical CreamPercent Reduction From Baseline for Oiliness at End of Treatment.90 percent reduction from baselineStandard Deviation 30
p-value: =0.8t-test, 2 sided
Secondary

Precent Reduction From Baseline for Scaling at End of Treatment.

Scaling score on a scale of 0 (none) to 4 (severe).

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

Population: All subjects will data after baseline were included in the analysis. For the Bland emollient group, 2 subjects were excluded from the analysis. For the Promiseb group, 3 subjects were excluded and one of the subjects that did not complete the study was included with Day 7 data carried forward to impute missing Day 14 data.

ArmMeasureValue (MEAN)Dispersion
Bland EmollientPrecent Reduction From Baseline for Scaling at End of Treatment.58 percent reduction from baselineStandard Deviation 62
Promiseb Topical CreamPrecent Reduction From Baseline for Scaling at End of Treatment.90 percent reduction from baselineStandard Deviation 22
p-value: =0.03t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026