Erythema, Sensitisation
Conditions
Brief summary
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.
Interventions
DEVICETest Article
Omeza Collagen Matrix
OTHERNegative Control
Occlusive Patch of 0.9% sodium chloride, NaCl
Sponsors
Omeza, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
The trained skin evaluator and Investigator was blinded to the identity of the test materials. Test/control sites were randomized within participants.
Intervention model description
The study design is based on a Modified Draize Human Repeat Insult Patch Test.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Good general health, as assessed by medical history and brief dermal skin examination of the application site (back); * Was fully informed of the risks of entering the study and was willing to provide written consent to enter the study; * Was willing to follow study rules, which included: no sun exposure (for example; no swimming, sunbathing, or tanning beds), avoided activities that would cause excessive sweating, abstained from use of lotions, creams, or oils on the back area; * Was willing to not change current brand of personal care products such as soaps, body washes, laundry detergents, body sprays, body spritzes, etc. while participating on the study; * Was willing and able to practice an acceptable measure of contraception (i.e. birth control medication for at least 3 months prior, condom with spermicide or birth control injections,) during the study, if female of childbearing potential. To be considered female of non-childbearing potential, subject must have had a hysterectomy, tubal ligation, or had been post-menopausal for at least 1 year.
Exclusion criteria
* Clinically significant skin disease which contraindicated participation, including psoriasis, eczema, atopic dermatitis, and active cancer; * Asthma that required medication; * Insulin-dependent diabetes; * Known immunological disorders such as HIV positive, AIDS and systemic lupus * erythematosus; * Treatment for any type of cancer within the last six months; * Routine use (as defined by using more than 3 days in a week) of any anti-inflammatory drug (e.g., aspirin, ibuprofen, corticosteroids; 81 mg aspirin is acceptable), immunosuppressive drugs, antihistamine medication (steroid nose drops and/or eye drops are acceptable) or over-the-counter pain medication that was ingested in quantities exceeding label instructions; * Use of topical drugs at patch site; * Pregnancy, lactation, or planning a pregnancy (confirmed by a urine pregnancy test administered to females of childbearing potential); * Medical condition which, in the Investigator's judgement, made the subject * ineligible or placed the subject at undue risk; * Participation in any patch test for irritation or sensitization within the last four weeks; * Dermatological aberrations in or around test sites which included sunburn, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or any other disfiguration of the test site; * Confirmed allergy to adhesives, bandages, or ingredients in OmezaTM Collagen Matrix; * History of anaphylaxis to matrix ingredients (e.g. fish, palm oil, hemp oil, beeswax).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | 24, 48, 72, and 96 Hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events Deemed Related to the Test Product or the Study | 6 weeks | The secondary outcome measure is the number of adverse events deemed related to the test article or the study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Article and Control Each subject will receive all investigational products at the same time.
Test Article: Omeza Collagen Matrix
Negative Control: Occlusive Patch of 0.9% sodium chloride, NaCl | 58 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Test Article and Control |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants |
| Age, Continuous | 49.4 years STANDARD_DEVIATION 11.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 36 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 58 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 58 |
| other Total, other adverse events | 1 / 58 |
| serious Total, serious adverse events | 0 / 58 |
Outcome results
Primary
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
Population: 58 subjects were enrolled with 53 subjects completing the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Article (Omeza Collagen Matrix) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 0 at 24 Hours | 53 Participants |
| Test Article (Omeza Collagen Matrix) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score + at 24 Hours | 0 Participants |
| Test Article (Omeza Collagen Matrix) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 1 at 24 Hours | 0 Participants |
| Test Article (Omeza Collagen Matrix) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 2 at 24 Hours | 0 Participants |
| Test Article (Omeza Collagen Matrix) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 3 at 24 Hours | 0 Participants |
| Test Article (Omeza Collagen Matrix) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 0 at 48 Hours | 52 Participants |
| Test Article (Omeza Collagen Matrix) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score + at 48 Hours | 1 Participants |
| Test Article (Omeza Collagen Matrix) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 1 at 48 Hours | 0 Participants |
| Test Article (Omeza Collagen Matrix) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 2 at 48 Hours | 0 Participants |
| Test Article (Omeza Collagen Matrix) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 3 at 48 Hours | 0 Participants |
| Test Article (Omeza Collagen Matrix) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 0 at 72 Hours | 53 Participants |
| Test Article (Omeza Collagen Matrix) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score + at 72 Hours | 0 Participants |
| Test Article (Omeza Collagen Matrix) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 1 at 72 Hours | 0 Participants |
| Test Article (Omeza Collagen Matrix) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 2 at 72 Hours | 0 Participants |
| Test Article (Omeza Collagen Matrix) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 3 at 72 Hours | 0 Participants |
| Test Article (Omeza Collagen Matrix) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 0 at 96 Hours | 53 Participants |
| Test Article (Omeza Collagen Matrix) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score + at 96 Hours | 0 Participants |
| Test Article (Omeza Collagen Matrix) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 1 at 96 Hours | 0 Participants |
| Test Article (Omeza Collagen Matrix) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 2 at 96 Hours | 0 Participants |
| Test Article (Omeza Collagen Matrix) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 3 at 96 Hours | 0 Participants |
| Negative Control (0.9% Aqueous Sodium Chloride) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 1 at 96 Hours | 0 Participants |
| Negative Control (0.9% Aqueous Sodium Chloride) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 0 at 24 Hours | 49 Participants |
| Negative Control (0.9% Aqueous Sodium Chloride) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 0 at 72 Hours | 50 Participants |
| Negative Control (0.9% Aqueous Sodium Chloride) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score + at 24 Hours | 4 Participants |
| Negative Control (0.9% Aqueous Sodium Chloride) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 0 at 96 Hours | 53 Participants |
| Negative Control (0.9% Aqueous Sodium Chloride) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 1 at 24 Hours | 0 Participants |
| Negative Control (0.9% Aqueous Sodium Chloride) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score + at 72 Hours | 3 Participants |
| Negative Control (0.9% Aqueous Sodium Chloride) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 2 at 24 Hours | 0 Participants |
| Negative Control (0.9% Aqueous Sodium Chloride) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 3 at 96 Hours | 0 Participants |
| Negative Control (0.9% Aqueous Sodium Chloride) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 3 at 24 Hours | 0 Participants |
| Negative Control (0.9% Aqueous Sodium Chloride) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 1 at 72 Hours | 0 Participants |
| Negative Control (0.9% Aqueous Sodium Chloride) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 0 at 48 Hours | 50 Participants |
| Negative Control (0.9% Aqueous Sodium Chloride) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score + at 96 Hours | 0 Participants |
| Negative Control (0.9% Aqueous Sodium Chloride) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score + at 48 Hours | 3 Participants |
| Negative Control (0.9% Aqueous Sodium Chloride) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 2 at 72 Hours | 0 Participants |
| Negative Control (0.9% Aqueous Sodium Chloride) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 1 at 48 Hours | 0 Participants |
| Negative Control (0.9% Aqueous Sodium Chloride) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 2 at 96 Hours | 0 Participants |
| Negative Control (0.9% Aqueous Sodium Chloride) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 2 at 48 Hours | 0 Participants |
| Negative Control (0.9% Aqueous Sodium Chloride) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 3 at 72 Hours | 0 Participants |
| Negative Control (0.9% Aqueous Sodium Chloride) | Evidence of Erythema During the Challenge Phase for Omeza Collagen Matrix | Frequency of Irritation Score 3 at 48 Hours | 0 Participants |
Secondary
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
Population: While only 53 subjects completed the study, a total of 58 subjects were enrolled. Therefore, adverse events were assessed in relation to the entire 58 patients who were enrolled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test Article (Omeza Collagen Matrix) | Adverse Events Deemed Related to the Test Product or the Study | 0 Adverse Events |
| Negative Control (0.9% Aqueous Sodium Chloride) | Adverse Events Deemed Related to the Test Product or the Study | 0 Adverse Events |