An interventional study of Test Article and Negative Control in Erythema and Sensitisation, sponsored by Omeza, LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-17.
Sponsored by Omeza, LLC · Not applicable, Interventional, and Basic science
Among 55 studies in Erythema with a site in United States — 8 open to participants now, 10 under way, none of them phase 3. Erythema · United States.
Among the 55 studies in Erythema with a site in United States, this one is the 25th largest by enrollment of the 52 interventional ones, is one of 2 that started in 2019, is one of 30 with no phase, and was the 43rd registered.
131 studies on the registry are indexed under Erythema; 17 are open to participants now.
This study's enrollment of 58 is above the median of 50 across 114 interventional studies indexed under Erythema.
Browse Erythema studies →8 of the 55 studies in Erythema with a site in United States are open now, in 9 countries. Each count lists the studies.
Of the 9 Erythema studies recruiting now, 7 (78%) set no upper age limit and 2 (22%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →55 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 2 started in 2019.
Median enrollment 52 across the 52 interventional studies, 104 across the 3 observational. Of the 45 that completed or were terminated, 27 (60%) have results posted.
30 of 55 have an industry lead sponsor. The 10 most frequent:
Omeza, LLC is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Omeza, LLC has 2 studies filed under Erythema — fewer than ten, so there is no comparison to draw.
4 of the studies in Erythema with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07172659Medicines Development for Global HealthEfficacy and Safety Study of Dovramilast in People With Leprosy Type 2 Reaction | 2027-01 |
| NCT06477172Acorn Biolabs Inc.Autologous Hair Follicle Derived Secretome as Adjunct to Aesthetic Procedures | 2027-02 |
| NCT07789639Good Molecules, LLCA Clinical Study to Evaluate the Efficacy and SPF of Two Test Materials According to an Adaptation of the Guidelines of the FDA Sunscreen Drug Products for Over-the-Counter Human Use | 2027-02-24 |
| NCT02876107M.D. Anderson Cancer CenterCarboplatin and Paclitaxel With or Without Panitumumab in Treating Patients With Invasive Triple Negative Breast Cancer | 2027-10-31 |
Among the 55 studies in Erythema with a site in United States, from their registry updates:
The primary objective of this study was to assess the sensitization potential of Omeza Collagen Matrix compared to that of a negative control based on a Modified Human Repeat Insult Patch Test.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Repetitive and continuous patch applications of the test article to the same test sites on the back approximately 48 hours on weekdays and for approximately 72-hour periods over weekends over 3 weeks, for a total of 9 induction applications. During a subsequent challenge phase 10-17 days after the induction phase, the test article and negative control will be applied for 48 hours. Each subject will receive both the test article and negative control at the same time.
Device: Test Article
Repetitive and continuous patch applications of the negative control to the same test sites on the back approximately 48 hours on weekdays and for approximately 72-hour periods over weekends over 3 weeks, for a total of 9 induction applications. During a subsequent challenge phase 10-17 days after the induction phase, the test article and negative control will be applied for 48 hours. Each subject will receive both the test article and negative control at the same time.
Other: Negative Control
Omeza Collagen Matrix
Occlusive Patch of 0.9% sodium chloride, NaCl
Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix
Erythema is evaluated during the challenge phase based on a numeric scale from 0 - 3 (0: No visible reaction, +: Slight/patchy, 1: Mild, 2: Moderate, 3: Strong). A score of 1, 2, or 3 indicates dermal sensitization.
Time frame: 24, 48, 72, and 96 Hours
Adverse Events Deemed Related to the Test Product or the Study
The secondary outcome measure is the number of adverse events deemed related to the test article or the study.
Time frame: 6 weeks
| Milestone | Test Article (Omeza Collagen Matrix) and Negative Control (Occlusive Patch of 0.9% NaCl) |
|---|---|
| Started | 58 |
| Completed | 53 |
| Not completed | 5 |
| Withdrew: Withdrawal by subject | 5 |
Erythema is evaluated during the challenge phase based on a numeric scale from 0 - 3 (0: No visible reaction, +: Slight/patchy, 1: Mild, 2: Moderate, 3: Strong). A score of 1, 2, or 3 indicates dermal sensitization.
| Participants | Test Article (Omeza Collagen Matrix) | Negative Control (0.9% Aqueous Sodium Chloride) |
|---|---|---|
| Frequency of Irritation Score 0 at 24 Hours | 53 | 49 |
| Frequency of Irritation Score + at 24 Hours | 0 | 4 |
| Frequency of Irritation Score 1 at 24 Hours | 0 | 0 |
| Frequency of Irritation Score 2 at 24 Hours | 0 | 0 |
| Frequency of Irritation Score 3 at 24 Hours | 0 | 0 |
| Frequency of Irritation Score 0 at 48 Hours | 52 | 50 |
| Frequency of Irritation Score + at 48 Hours | 1 | 3 |
| Frequency of Irritation Score 1 at 48 Hours | 0 | 0 |
| Frequency of Irritation Score 2 at 48 Hours | 0 | 0 |
| Frequency of Irritation Score 3 at 48 Hours | 0 | 0 |
| Frequency of Irritation Score 0 at 72 Hours | 53 | 50 |
| Frequency of Irritation Score + at 72 Hours | 0 | 3 |
| Frequency of Irritation Score 1 at 72 Hours | 0 | 0 |
| Frequency of Irritation Score 2 at 72 Hours | 0 | 0 |
| Frequency of Irritation Score 3 at 72 Hours | 0 | 0 |
| Frequency of Irritation Score 0 at 96 Hours | 53 | 53 |
| Frequency of Irritation Score + at 96 Hours | 0 | 0 |
| Frequency of Irritation Score 1 at 96 Hours | 0 | 0 |
| Frequency of Irritation Score 2 at 96 Hours | 0 | 0 |
| Frequency of Irritation Score 3 at 96 Hours | 0 | 0 |
The secondary outcome measure is the number of adverse events deemed related to the test article or the study.
| Adverse Events | Test Article (Omeza Collagen Matrix) | Negative Control (Occlusive Patch of 0.9% NaCl) |
|---|---|---|
| Adverse Events Deemed Related to the Test Product or the Study | 0 | 0 |
Collected over Adverse events were monitored throughout the study with each patient monitored over the 6 weeks of treatment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Article (Omeza Collagen Matrix) and Negative Control | 0/58 (0%) | 0/58 (0%) | 1/58 (1.7%) |
| Event | Test Article (Omeza Collagen Matrix) and Negative Control |
|---|---|
| InfluenzaRespiratory, thoracic and mediastinal disorders | 1/58 |
| Age, Categorical(Participants) | Test Article and Control |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 58 |
| >=65 years | 0 |
| Age, Continuous(years) | Test Article and Control |
|---|---|
| Mean | 49.4 ± 11.4 |
| Sex: Female, Male(Participants) | Test Article and Control |
|---|---|
| Female | 50 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | Test Article and Control |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 56 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Test Article and Control |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 36 |
| White | 19 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Test Article and Control |
|---|---|
| United States | 58 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2019 to primary completion in Jan 2020, 1 month.
Results were first posted in May 2023, 3 years 4 months after primary completion.
Of 43 interventional studies with no phase under Erythema, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 11. This study's 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Omeza, LLC