HistologyNCT04846530
Teosyal RHA® Histology and Intradermal Implantation Evaluation Study
An observational study of Histology, run by Revance Therapeutics, Inc. at 1 site in Canada.
Trial summary
The Teosyal RHA® family of products (RHA® 1, RHA® 2, RHA® 3, and RHA® 4) is approved in Canada for the correction of facial wrinkles and folds. In this study, the approved products will be placed in small boluses (0.2 mL) intradermally to allow for punch biopsies of the post-auricular space to be taken. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Histology
- What is being tested?
- RHA® 1, RHA® 2, RHA® 3, and RHA® 4
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 20 Aug 2021to 13 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All healthy subjects who fulfill the entry criteria (inclusion and exclusion) will be considered for study recruitment.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single Blind, Single-center Study Evaluating the Histology and Intradermal Implantation of the Teosyal RHA® Collection of Fillers
The Teosyal RHA® family of products (RHA® 1, RHA® 2, RHA® 3, and RHA® 4) is approved in Canada for the correction of facial wrinkles and folds. In this study, the approved products will be placed in small boluses (0.2 mL) intradermally to allow for punch biopsies of the post-auricular space to be taken. The biopsies will include the injected material and surrounding skin tissue. Biopsies will be taken immediately after implantation of the product and at Day 30 and assessed by an independent blinded pathologist.
- Conditions
- Histology
- Being tested
- RHA® 1, RHA® 2, RHA® 3, and RHA® 4
- Keywords
- Histology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RHA® 1, RHA® 2, RHA® 3, and RHA® 4Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: RHA® 1, RHA® 2, RHA® 3, and RHA® 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsy specimens
The biopsy specimens will be submitted to an independent laboratory for histological examination.
Measured: Day 1
Secondary outcomes (1)
Biopsy specimens
The biopsy specimens will be submitted to an independent laboratory for histological examination.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start20 Aug 2021
- Primary completion7 Oct 2021
- Study completion13 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HistologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revance Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846530
- Sponsor's protocol ID
- 2030403
- Status last verified
- Nov 2021
- First submitted
- 9 Apr 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Blind, Single-center Study Evaluating the Histology and Intradermal Implantation of the Teosyal RHA® Collection of Fillers
- ClinicalTrials.gov ID
- NCT04846530
- Acronym / sponsor ID
- 2030403
- Conditions
- Histology
- Keywords
- Histology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Revance Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 13 Dec 2021 (estimated)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Teosyal RHA® family of products (RHA® 1, RHA® 2, RHA® 3, and RHA® 4) is approved in Canada for the correction of facial wrinkles and folds. In this study, the approved products will be placed in small boluses (0.2 mL) intradermally to allow for punch biopsies of the post-auricular space to be taken. The biopsies will include the injected material and surrounding skin tissue. Biopsies will be taken immediately after implantation of the product and at Day 30 and assessed by an independent blinded pathologist.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Approved products will be placed in small boluses (0.2 mL) intradermally | – | Device: RHA® 1, RHA® 2, RHA® 3, and RHA® 4Subjects will be assigned to receive two products each from the RHA® line of products (RHA® 1, RHA® 2, RHA® 3, and RHA® 4). |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All healthy subjects who fulfill the entry criteria (inclusion and exclusion) will be considered for study recruitment.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RHA® 1, RHA® 2, RHA® 3, and RHA® 4For 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. | Device | Approved products will be placed in small boluses (0.2 mL) intradermally |
Primary outcome
Biopsy specimens
Time frame: Day 1
The biopsy specimens will be submitted to an independent laboratory for histological examination.
1 secondary outcome
Biopsy specimens
Time frame: Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
Related trials for Histology
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma
Active, not recruitingObservational study
A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection - The ON-SITE Study
Lung Biopsy, Lung Cancer
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruitingPhase 2
A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS
Carcinoma, Non-Small-Cell Lung
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Histology, run by Revance Therapeutics, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biopsy specimens (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.