Trial Outcomes & Findings for Promiseb Topical Cream for Cradle Cap (NCT NCT01214434)

Results Overview

IGA scored on scale of 0 (clear) to 4 (severe).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

42 participants

Primary outcome timeframe

end of treatment (Day 7 or 14)

Results posted on

2017-03-07

Participant Flow

Participant milestones

Participant milestones
Measure	Bland Emollient Bland emollient : Eucerin cream twice daily	Promiseb Topical Cream Promiseb Topical Cream : topical non steroidal cream, twice daily
Overall Study STARTED	15	27
Overall Study COMPLETED	11	25
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Bland Emollient Bland emollient : Eucerin cream twice daily	Promiseb Topical Cream Promiseb Topical Cream : topical non steroidal cream, twice daily
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	2	2
Overall Study Site error	1	0

Baseline Characteristics

Promiseb Topical Cream for Cradle Cap

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bland Emollient n=15 Participants Bland emollient : Eucerin cream twice daily	Promiseb Topical Cream n=27 Participants Promiseb Topical Cream : topical non steroidal cream, twice daily	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=93 Participants	27 Participants n=4 Participants	42 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	1.5 years STANDARD_DEVIATION 3.5 • n=93 Participants	0.8 years STANDARD_DEVIATION 1.6 • n=4 Participants	1.0 years STANDARD_DEVIATION 2.3 • n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	11 Participants n=4 Participants	20 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	16 Participants n=4 Participants	22 Participants n=27 Participants
Region of Enrollment United States	15 participants n=93 Participants	27 participants n=4 Participants	42 participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

IGA scored on scale of 0 (clear) to 4 (severe).

Outcome measures

Outcome measures
Measure	Bland Emollient n=13 Participants Bland emollient : Eucerin cream twice daily	Promiseb Topical Cream n=25 Participants Promiseb Topical Cream : topical non steroidal cream, twice daily
Subjects With Investigator Global Assessment (IGA) Success (IGA of 0 or 1) at End of Treatment (Day 7 or 14).	91.7 percentage of participants	96 percentage of participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Bland Emollient n=12 Participants Bland emollient : Eucerin cream twice daily	Promiseb Topical Cream n=25 Participants Promiseb Topical Cream : topical non steroidal cream, twice daily
Number of Participants With Excellent Overall Safety Score at End of Treatment.	12 participants	25 participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Bland Emollient n=12 Participants Bland emollient : Eucerin cream twice daily	Promiseb Topical Cream n=25 Participants Promiseb Topical Cream : topical non steroidal cream, twice daily
Precent Reduction From Baseline for Scaling at End of Treatment.	58 percent reduction from baseline Standard Deviation 62	90 percent reduction from baseline Standard Deviation 22

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Bland Emollient n=12 Participants Bland emollient : Eucerin cream twice daily	Promiseb Topical Cream n=25 Participants Promiseb Topical Cream : topical non steroidal cream, twice daily
Percent Reduction From Baseline for Crusting at End of Treatment.	85 percent reduction from baseline Standard Deviation 22	78 percent reduction from baseline Standard Deviation 48

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Bland Emollient n=12 Participants Bland emollient : Eucerin cream twice daily	Promiseb Topical Cream n=25 Participants Promiseb Topical Cream : topical non steroidal cream, twice daily
Percent Reduction From Baseline for Erythema at End of Treatment.	74 percent reduction from baseline Standard Deviation 43	89 percent reduction from baseline Standard Deviation 26

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Bland Emollient n=12 Participants Bland emollient : Eucerin cream twice daily	Promiseb Topical Cream n=25 Participants Promiseb Topical Cream : topical non steroidal cream, twice daily
Percent Reduction From Baseline for Oiliness at End of Treatment.	88 percent reduction from baseline Standard Deviation 23	90 percent reduction from baseline Standard Deviation 30

Adverse Events

Bland Emollient

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Promiseb Topical Cream

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bland Emollient n=12 participants at risk Bland emollient : Eucerin cream twice daily	Promiseb Topical Cream n=25 participants at risk Promiseb Topical Cream : topical non steroidal cream, twice daily
Respiratory, thoracic and mediastinal disorders Strep throat	8.3% 1/12 • Number of events 1	0.00% 0/25

Additional Information

Medical Information Center

Promius Pharma, LLC

Phone: 888 966-8766

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60