An interventional study of NeoMatriX Collagen Dressing in Dermatitis, Allergy and Contact Allergy, sponsored by NeXtGen Biologics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-16.
Sponsored by NeXtGen Biologics, Inc. · Not applicable, Interventional, and Other
Repeated insult patch test on healthy males and females to determine potential contact irritation or contact allergy in the skin
238 studies on the registry are indexed under Dermatitis; 34 are open to participants now.
This study's enrollment of 68 is close to the median of 68 across 191 interventional studies indexed under Dermatitis.
Browse Dermatitis studies →NeXtGen Biologics, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NeoMatriX Collagen Dressing and Comparators - positive control and normal saline will be applied to the absorbent pad portion of the exclusive dressing.
Device: NeoMatriX Collagen Dressing
Collagen wound dressing
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.
Time frame: 3 weeks
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.
Time frame: 5 weeks
| Milestone | Collagen Dressing and Comparator |
|---|---|
| Started | 68 |
| Completed | 54 |
| Not completed | 14 |
Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction.
| erythema score | NeoMatriX | Positive Control | Negative Control |
|---|---|---|---|
| Erythema at the Patch Test Site is Evaluated for Each Participant | 0.00 (0 to 0) | 0.59 (0 to 1) | 0.00 (0 to 0.5) |
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.
| erythema score | NeoMatriX | Positive Control | Negative Control |
|---|---|---|---|
| Sensitization Reactions | 0 (0 to 0) | — | — |
Collected over 40 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Collagen Dressing and Comparator | 0/68 (0%) | 0/68 (0%) | 0/68 (0%) |
| Age, Categorical(Participants) | Collagen Dressing and Comparator |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 59 |
| >=65 years | 8 |
| Age, Continuous(years) | Collagen Dressing and Comparator |
|---|---|
| Mean | 46 (18 to 79) |
| Sex: Female, Male(Participants) | Collagen Dressing and Comparator |
|---|---|
| Female | 44 |
| Male | 24 |
| Race and Ethnicity Not Collected(Participants) | Collagen Dressing and Comparator |
|---|
| Region of Enrollment(participants) | Collagen Dressing and Comparator |
|---|---|
| United States | 68 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
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NeXtGen Biologics, Inc.