Healthy Adult
Conditions
Keywords
skin irritation, skin sensitization, HRIPT, Fibrous Collagen Matrix
Brief summary
This study evaluates skin irritation and sensitization following repeated application of a collagen-based material in healthy adult volunteers under controlled conditions. Skin responses will be assessed during study participation.
Interventions
DEVICECollagen-Based Material
A collagen-based material applied under occlusive patch conditions to assess skin irritation and sensitization in healthy adult participants.
Sponsors
SerenaGroup, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 18 to 70 years * Male and female participants * Fitzpatrick Skin Types I and VI * Participants of any race * Participants of any ethnicity (Hispanic or Latino or Not Hispanic or Latino) * Generally healthy, without dermatological or systemic conditions that could interfere with study participation or evaluation of results, as determined by the investigator * Able to read and understand English and provide written informed consent * Able to comply with study procedures and complete all required visits * Willing to have test materials applied according to the study protocol * Has not participated in a similar clinical study within the previous 30 days * Agrees to avoid excessive sun exposure, sunbathing, or tanning during study participation * Female participants of childbearing potential willing to undergo pregnancy testing prior to participation * Agrees not to change current personal care products during study participation
Exclusion criteria
* Use of medications that may interfere with study results (e.g., corticosteroids, antihistamines, immunosuppressive agents, or high-dose NSAIDs) * History of acute or chronic medical conditions that could interfere with study participation or increase risk (e.g., autoimmune disease, HIV infection) * Chronic skin conditions such as atopic dermatitis or eczema * Treatment for skin cancer within the previous 12 months * Abnormal or damaged skin at test sites that could interfere with evaluation (e.g., sunburn, tattoos, scars, active dermatologic conditions) * Diabetes requiring insulin therapy * Pregnant, planning pregnancy, or breastfeeding * Known hypersensitivity to personal care products, cosmetics, fragrances, or adhesives * Known fish allergy * Any condition that, in the opinion of the investigator, may compromise participant safety or study integrity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dermal Irritation Score Using the International Contact Dermatitis Research Group (ICDRG) Scale | During the induction phase (approximately 3 consecutive weeks) | Dermal irritation response will be assessed using the International Contact Dermatitis Research Group (ICDRG) skin reaction grading scale (0-4). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Allergic Contact Sensitization Response Using ICDRG Scale | Through completion of all skin assessments during the study (approximately 5-6 weeks) | Allergic contact sensitization response will be assessed using the International Contact Dermatitis Research Group (ICDRG) skin reaction grading scale (0-4) following challenge exposure |
Countries
United States
Outcome results
None listed