- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04846530
Teosyal RHA® Histology and Intradermal Implantation Evaluation Study
A Prospective, Single Blind, Single-center Study Evaluating the Histology and Intradermal Implantation of the Teosyal RHA® Collection of Fillers
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
-
Woodbridge, Ontario, Canada, L4L 8E2
- Woodbridge, Ontario Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
1. Outpatient, male or non-pregnant, non-nursing females, at least 22 years of age, and in good general health.
2. Subject willing to abstain from other aesthetic procedures on the head or face including receiving other dermal fillers, laser treatments, use of any product that affects skin remodeling, or a product that may cause an active dermal response in the treatment area from screening through the last study follow-up visit.
3. Female subjects of childbearing potential must have a negative urine pregnancy test result at the Treatment Visit, prior to product administration.
4. Able to understand the requirements of the trial and sign informed consent including authorization to release health information.
5. Subject willing and able to comply with study follow-up procedures and schedule.
6. Subject willing to provide written informed consent for their participation in the study including authorization to release health information.
Exclusion Criteria:
1. Subject is a female of childbearing potential (e.g., not postmenopausal for at least one year or has not had a hysterectomy or tubal ligation) not using medically effective birth control (e.g., hormonal methods such as birth control pills; implants; Intrauterine Device (IUDs), etc., in use at least 30 days prior to injection or barrier methods such as condom and spermicide in use at least 14 days prior to injection), or is pregnant, lactating, or plans to become pregnant during the study.
2. Subject has participated in a clinical study in which an investigational device or drug was received in the 30 days prior to screening or plans to enroll in such a study during the course of the current study.
3. Subject is an employee or direct relative of an employee of the investigational site or Sponsor.
4. Subject has a serious or progressive disease, which, in the investigator's judgment, puts the subject at undue risk (e.g., uncontrolled diabetes, autoimmune pathology, cardiac pathologies).
5. Subject has a local acute inflammatory process or infection, or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of adverse events.
6. Subject has a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder.
7. Subject has had an active skin disease in the treatment area within the past 6 months.
8. Subject has scars, infection, rosacea, herpes, acne, blotches or other pathology behind the ears. Subject is predisposed to keloidosis or hypertrophic scarring.
9. Subject has known allergy to hyaluronic acid, 1,4-butanediol diglycidyl ether (BDDE), gram-positive bacterial proteins or streptococcal proteins.
10. Subject has history of hypersensitivity to local anesthetics of the amide type, such as lidocaine.
11. Subject has severe allergies as manifested by a history of anaphylaxis, or a history or presence of multiple severe allergies.
12. Subject has a known bleeding disorder. 13. Subject has received or plans to receive within 1 week prior to injection through 1 week following or in the one week prior to 30 day biopsy through 1 week after any treatment/procedure that may impact coagulation such as high-dose Vitamin E, aspirin, anti-inflammatories, antiplatelets, thrombolytics, or any other medication that could increase the risk of bleeding. Subject has received within the past 3 months or plans to receive during the study chemotherapy agents, immunosuppressive medications, or systemic corticosteroids (inhaled steroids are acceptable).
14. Subject has received within the past 12 months or plans to receive during the study any treatment or procedure involving the post-auricular area.
15. Any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the trial results, or may interfere significantly with the subject's participation in the trial.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Approved products will be placed in small boluses (0.2 mL) intradermally
Subjects will be assigned to receive two products each from the RHA® line of products (RHA® 1, RHA® 2, RHA® 3, and RHA® 4).
|
For each subject, two spaced boluses (0.2 mL each) of the product will be implanted on the same side (left or right side) in the post auricular area of the subject per treatment assignment.
The assignment will specify one of the RHA® products to the left ear and another product to the right ear.
Each subject will have a total of four boluses.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biopsy specimens
Time Frame: Day 1
|
The biopsy specimens will be submitted to an independent laboratory for histological examination.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biopsy specimens
Time Frame: Day 30
|
The biopsy specimens will be submitted to an independent laboratory for histological examination.
|
Day 30
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2030403
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Histology
-
Tianjin Chest HospitalUnknownPercutaneous Coronary Intervention | Saphenous Vein Graft Disease | Major Adverse Cardiovascular Events | Virtual Histology Intravascular UltrasoundChina
-
Agensys, Inc.CompletedCarcinoma, Renal Cell | Renal Cell Carcinoma of Papillary Histology | Renal Cell Carcinoma With Clear Cell Histology | Renal Cell Carcinoma With Non-Clear Cell HistologyUnited States, Canada
-
Washington University School of MedicineCompletedHumans | Histology | Herniorrhaphy | Materials Testing | Polytetrafluoroethylene | PolypropyleneUnited States
-
Universidad de AntioquiaCompletedLaser | Intrusion | Histology | ResorptionColombia
-
Petz Aladar County Teaching HospitalCompletedSoftware Analysis on Polyp Histology Prediction
-
Govind Ballabh Pant HospitalUnknownMetabolic Parameters and Liver HistologyIndia
-
University of LiegeITI International Team for Implantology, SwitzerlandCompletedDental Implantation | Dental Implants | Soft Tissue Inflammation | Histology | Immunohistochemistry | Dental Implants, Single-ToothBelgium
-
Shandong UniversityRecruitingUlcerative Colitis | Mucosal Healing | Histology Remission | Fecal Calprotetin | FITChina
-
IRCCS San RaffaeleCompletedThymoma | Computed Tomography | Prognostic Factors | Histology | Staging
-
AerasStatens Serum InstitutCompletedLatent Tuberculosis | Latent Tuberculosis Bacteriology and Histology UnknownSouth Africa
Clinical Trials on RHA® 1, RHA® 2, RHA® 3, and RHA® 4
-
Teoxane SAActive, not recruitingSkin Aging | Fine Lines of the Face and NeckSpain
-
Teoxane SAethica Clinical Research Inc.CompletedNasolabial Folds, WrinklesUnited States
-
Merck Sharp & Dohme LLCCompletedMeasles | Rubella | Mumps | Varicella
-
Merck Sharp & Dohme LLCCompletedMeasles | Mumps | VaricellaFrance, Germany
-
Teoxane SAethica Clinical Research Inc.CompletedNasolabial Folds, WrinklesUnited States
-
Teoxane SANot yet recruiting
-
SanofiProtein Sciences CorporationCompletedInfluenzaUnited States
-
Teoxane SACompleted