Cradle CapPhase 4NCT01214434

Promiseb Topical Cream for Cradle Cap

A Phase 4 study testing Promiseb Topical Cream and Bland emollient in people with Cradle Cap and Infantile Seborrheic Dermatitis, run by Promius Pharma, LLC at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 30 days and older
Conditions the study is for: Cradle Cap, Infantile Seborrheic Dermatitis
What is being tested?: Promiseb Topical Cream and Bland emollient
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 42 participants
Where: 4 sitesUnited States
Study dates: Mar 2010to Jun 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 days and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Derm Research
Louisville, Kentucky, 40217
UMDNJ
Newark, New Jersey, 07101
Norwich Pediatric Group
Norwich, Connecticut, 06360
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official 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)

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
Being tested: Promiseb Topical Cream, Bland emollient
Keywords: Cradle Cap, Infantile seborrheic Dermatitis
Medical subject headings: Dermatitis, Seborrheic, Complement component 5 deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Promiseb Topical CreamDevice
topical non steroidal cream, twice daily
Bland emollientOther
Eucerin cream twice daily

Study groups in NCT01214434
Study group	Role	What they receive
Promiseb Topical Cream	Experimental	Not described Receives: Device: Promiseb Topical Cream
Bland emollient	Sham comparator	Not described Receives: Other: Bland emollient

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: End of treatment

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Jun 2011

First posted5 Oct 2010 (estimated)
Study startMar 2010
Primary completionJun 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cradle CapStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01214434
Sponsor's protocol ID: PSC0903
Status last verified: Jan 2017
First submitted: 28 Sep 2010
Last updated: 7 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
TRIDERM D.S. Crema Normalizzante for Neonatal Hyperseborrhea (Cradle Cap) and Associated Cutaneous Manifestations of Mild-to-Moderate Seborrheic Dermatitis in Children Aged 0 to 3 Years
Cradle Cap, Seborrheic Dermatitis
Not yet recruitingPhase 3
Efficacy and Safety of Roflumilast Foam 0.3% in Trial Participants With Seborrheic Dermatitis
Seborrheic Dermatitis
RecruitingEarly Phase 1
The Effectiveness of Itraconazole Pulse Therapy vs Topical 2% Ketoconazole in the Treatment of Moderate to Severe Seborrheic Dermatitis of Scalp.
Seborrheic Dermatitis
RecruitingPhase 1
ZYG24002 Lotion to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy in Adult Patients With Mild to Moderate Seborrheic Dermatitis
Seborrheic Dermatitis
Recruiting
A Study on Scalp Health and Integrated Scalp Management Protocols for Hair Transplant Patients
Hair Transplantation, Seborrheic Dermatitis

All Cradle Cap trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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)
ClinicalTrials.gov ID: NCT01214434
Acronym / sponsor ID: PSC0903
Conditions: Cradle Cap, Infantile Seborrheic Dermatitis
Keywords: Cradle Cap, Infantile seborrheic Dermatitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Promius Pharma, LLCIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 5 Oct 2010 (estimated)
Results: Posted 20 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Promiseb Topical Cream	Experimental	Device: Promiseb Topical Cream
Bland emollient	Sham comparator	Other: Bland emollient

Who may qualify

Ages: 30 days and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Promiseb Topical Creamtopical non steroidal cream, twice daily	Device	Promiseb Topical Cream
Bland emollientEucerin cream twice daily	Other	Bland emollient

Primary outcome

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).
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).

4 secondary outcomes

Precent Reduction From Baseline for Scaling at End of Treatment.
Time frame: From Baseline to end of treatment (Day 7 or 14)
Percent Reduction From Baseline for Crusting at End of Treatment.
Time frame: From Baseline to end of treatment (Day 7 or 14)
Percent Reduction From Baseline for Erythema at End of Treatment.
Time frame: From Baseline to end of treatment (Day 7 or 14)
Percent Reduction From Baseline for Oiliness at End of Treatment.
Time frame: From Baseline to end of treatment (Day 7 or 14)

Results and safety

Results posted to the registry on 20 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bland Emollient	15	11
Promiseb Topical Cream	27	25

Primary outcome: 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). Number. Unit: percentage of participants

Measure	Bland Emollient n = 13	Promiseb Topical Cream n = 25
Value	91.7	96

Bland Emollient vs Promiseb Topical Cream: p >0.05, Chi-squared

Population analysed: 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.

Primary outcome: Number of Participants With Excellent Overall Safety Score at End of Treatment.

Time frame: End of treatment. Number. Unit: participants

Measure	Bland Emollient n = 12	Promiseb Topical Cream n = 25
Value	12	25

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bland Emollient	0 of 12 (0%)	1 of 12 (8.3%)	Not reported
Promiseb Topical Cream	0 of 25 (0%)	0 of 25 (0%)	Not reported

Limitations and caveats (from the sponsor): Small number of subjects enrolled and analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cradle Cap

Not yet recruiting
TRIDERM D.S. Crema Normalizzante for Neonatal Hyperseborrhea (Cradle Cap) and Associated Cutaneous Manifestations of Mild-to-Moderate Seborrheic Dermatitis in Children Aged 0 to 3 Years
Cradle Cap, Seborrheic Dermatitis
Not yet recruitingPhase 3
Efficacy and Safety of Roflumilast Foam 0.3% in Trial Participants With Seborrheic Dermatitis
Seborrheic Dermatitis
RecruitingEarly Phase 1
The Effectiveness of Itraconazole Pulse Therapy vs Topical 2% Ketoconazole in the Treatment of Moderate to Severe Seborrheic Dermatitis of Scalp.
Seborrheic Dermatitis
RecruitingPhase 1
ZYG24002 Lotion to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy in Adult Patients With Mild to Moderate Seborrheic Dermatitis
Seborrheic Dermatitis
Recruiting
A Study on Scalp Health and Integrated Scalp Management Protocols for Hair Transplant Patients
Hair Transplantation, Seborrheic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joanne M Fraser, PhD study director

Promius Pharma

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Promiseb Topical Cream and Bland emollient in people with Cradle Cap and Infantile Seborrheic Dermatitis, run by Promius Pharma, LLC at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01214434.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.