DermatitisNCT03474874

Human Repeated Insult Patch Test

A study testing NeoMatriX Collagen Dressing in people with Dermatitis and Allergy, run by NeXtGen Biologics, Inc. at 1 site 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

Repeated insult patch test on healthy males and females to determine potential contact irritation or contact allergy in the skin Read more about this study

Who is it for?: Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for: Dermatitis, Allergy, Contact Allergy
What is being tested?: NeoMatriX Collagen Dressing
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 1 siteUnited States
Study dates: 26 Feb 2018to 6 Apr 2018
Phase: Interventional
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 18 to 79 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adults;
Subjects must understand and execute an Informed Consent Form that includes a HIPAA statement;
Subjects must be considered dependable and able to follow directions

Who cannot join

Subjects who are in ill health;
Subjects who are taking medications other than birth control;
Female subjects who are pregnant (return positive urine pregnancy test), planning to become pregnant or lactating during the course of the trial;
Subjects who have a history of adverse reactions to personal care products, or known sensitivity to the test materials or their constituents including patch materials;
Subjects with any active skin disease;
Subjects who have heavy alcohol consumption;

Show all 9Show fewer

Subjects with current use or history of repeated use of street drugs;
Subjects with a significant past medical history to potentially effect results of study;
Subjects with immunization less than 10 days prior to the test patch application;

Trial locations and contacts

1 site in 1 country.

United States1 site

Consumer Product Testing Company, Inc.
Fairfield, New Jersey, 07004

Other trials in United States

About this study

Repeated insult patch test on healthy males and females to determine potential contact irritation or contact allergy in the skin

Conditions: Dermatitis, Allergy, Contact Allergy
Being tested: NeoMatriX Collagen Dressing
Medical subject headings: Dermatitis, Hypersensitivity, Dermatitis, Allergic Contact

What participants receive

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

NeoMatriX Collagen DressingDevice
Collagen wound dressing

Study groups in NCT03474874
Study group	Role	What they receive
Collagen Dressing and Comparator	Other	NeoMatriX Collagen Dressing and Comparators - positive control and normal saline will be applied to the absorbent pad portion of the exclusive dressing. Receives: Device: NeoMatriX Collagen Dressing

What is being measured

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

Erythema at the Patch Test Site is Evaluated for Each Participant
Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction.
Measured: 3 weeks

Secondary outcomes (1)

Sensitization Reactions
Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction.
Allergic Dermal Sensitization Potential - Erythema will be evaluated at the patch site for only the test material (positive and negative control will not be evaluated). Sensitization reactions will be determined at the patch test site after a two week rest period for each participant (similar to a "wash-out period"). The patch test site will be tested on the same study subject population, but using a virgin test site.
Measured: 5 weeks

Timeline

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

26 Feb 20186 Apr 2018

First posted23 Mar 2018
Study start26 Feb 2018
Primary completion6 Apr 2018
Study completion6 Apr 2018

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 DermatitisStudies 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 N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03474874
Sponsor's protocol ID: NNAU01-001
Status last verified: May 2019
First submitted: 15 Mar 2018
Last updated: 16 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

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

Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
Enrolling by invitationPhase 3
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingEarly Phase 1
Adapalene Gel for Acute Radiation-Induced Skin Injury
Radiation Dermatitis

All Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Human Repeated Insult Patch Test
ClinicalTrials.gov ID: NCT03474874
Acronym / sponsor ID: NNAU01-001
Conditions: Dermatitis, Allergy, Contact Allergy
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: NeXtGen Biologics, Inc.Industry (pharma, biotech, devices)
Study start: 26 Feb 2018 (actual)
Primary completion: 6 Apr 2018 (actual)
Study completion: 6 Apr 2018 (actual)
First posted: 23 Mar 2018 (actual)
Results: Posted 10 May 2019

Clinical summary

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

Repeated insult patch test on healthy males and females to determine potential contact irritation or contact allergy in the skin

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Collagen Dressing and Comparator	Other	Device: NeoMatriX Collagen DressingNeoMatriX Collagen Dressing and Comparators - positive control and normal saline will be applied to the absorbent pad portion of the exclusive dressing.

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adults;
Subjects must understand and execute an Informed Consent Form that includes a HIPAA statement;
Subjects must be considered dependable and able to follow directions

Key exclusion criteria (9 listed)

Subjects who are in ill health;
Subjects who are taking medications other than birth control;
Female subjects who are pregnant (return positive urine pregnancy test), planning to become pregnant or lactating during the course of the trial;
Subjects who have a history of adverse reactions to personal care products, or known sensitivity to the test materials or their constituents including patch materials;
Subjects with any active skin disease;

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
NeoMatriX Collagen DressingCollagen wound dressing	Device	Collagen Dressing and Comparator

Primary outcome

Erythema at the Patch Test Site is Evaluated for Each Participant
Time frame: 3 weeks
Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction.

1 secondary outcome

Sensitization Reactions
Time frame: 5 weeks

Results and safety

Results posted to the registry on 10 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Collagen Dressing and Comparator	68	54

Primary outcome: Erythema at the Patch Test Site is Evaluated for Each Participant

Time frame: 3 weeks. Mean (Full Range). Unit: erythema score

Measure	NeoMatriX n = 54	Positive Control n = 54	Negative Control n = 54
Value	0.00 (0 to 0)	0.59 (0 to 1)	0.00 (0 to 0.5)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 40 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Collagen Dressing and Comparator	0 of 68 (0%)	0 of 68 (0%)	0 of 68

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Dermatitis

Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
Enrolling by invitationPhase 3
A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingEarly Phase 1
Adapalene Gel for Acute Radiation-Induced Skin Injury
Radiation 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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing NeoMatriX Collagen Dressing in people with Dermatitis and Allergy, run by NeXtGen Biologics, Inc. at 1 site 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 3 inclusion and 9 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 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 May 2019). 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?

Erythema at the Patch Test Site is Evaluated for Each Participant (time frame: 3 weeks). 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 NCT03474874.

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 16 Jul 2019.