Submental Fat (SMF)Phase 1NCT04821648
RJV001 Study in Adults Receiving Abdominoplasty
A Phase 1 study testing RJV001 in people with Submental Fat (SMF) and Double Chin, run by Rejuven Dermaceutical Co., Ltd. at 1 site in United States.
Trial summary
In this study, we are testing a new drug against submental fat (SMF), which is characterized with the accumulation of fat under the chin that often appears as a "double chin". The 2018 American Society for Dermatologic Surgery Consumer Survey on Cosmetic Dermatologic Procedures indicated that 73% of respondents were… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Submental Fat (SMF), Double Chin
- What is being tested?
- RJV001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2021to 16 Dec 2021
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is a male or non-pregnant female 18-65 years of age.
- Subject has provided written informed consent.
- Females must be post-menopausal , surgically sterile , or use an effective method of birth control. , Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Screening and Visit 2/Baseline.
- Subject is scheduled on a specific date to undergo abdominoplasty and meets all pre-operative requirements, in the opinion of the investigator.
- Subject is willing to undergo test article injections as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
- Subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of the test article injection sites or expose the subject to an unacceptable risk by study participation.
Who cannot join
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has a significant active systemic or localized abdominal infection.
- Subject has any medical condition that affects clotting and/or platelet function (e.g., thromboembolic disease, clotting factor deficiencies such as hemophilia).
- Subject is taking any medications that affect clotting and/or platelet function. This includes, but is not limited to, nonsteroidal anti-inflammatory medications (including low dose aspirin for prophylaxis), heparin (including low molecular weight heparin), Coumadin, and factor Xa agents such as Clopidogrel bisulfate (Plavix) and apixaban (Eliquis), etc. The use of such medications is precluded within 7 days prior to Visit 2/Baseline.
- Subject is immunocompromised, in the opinion of the investigator, based on their medical condition (e.g., positive for human immunodeficiency virus, malignancy), medication use, or other factors.
- Subject has any clinically significant medical abnormality or chronic disease of the cardiovascular, gastrointestinal, respiratory (e.g., chronic obstructive pulmonary disease), hepatic, or renal systems. This includes conditions (e.g., gastrointestinal surgery) that may interfere with metabolism or excretion.
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- Subject is currently enrolled in an investigational drug or device study.
- Subject has used an investigational drug or investigational device treatment within 30 days prior to Visit 2/Baseline.
- Subject has a history of sensitivity to RJV001, other collagenases, or any of the other ingredients in the test articles.
- Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Study site: Arizona Research Center
Phoenix, Arizona, 85053
About this study
Official title: A Study of the Safety, Tolerability, and Clinical Pharmacology of Subcutaneous Rjv001 in Adult Subjects Undergoing Abdominoplasty
In this study, we are testing a new drug against submental fat (SMF), which is characterized with the accumulation of fat under the chin that often appears as a "double chin". The 2018 American Society for Dermatologic Surgery Consumer Survey on Cosmetic Dermatologic Procedures indicated that 73% of respondents were bothered by "excess fat under the chin/neck". This condition of loose or sagging skin under the chin may affect facial symmetry and attractiveness, which can lead to social embarrassment and a negative self-image in many patients.
There is an insufficiency in effective drugs against SMF and double chin. Although an injectable small molecule can be used for improvement of double chin, but its side effects are evident and its cost is high. As such, there remains a real need to develop a cost-effective method to improve appearance of SMF and double chin.
Read the detailed description
The therapies directed against adipocytes represent a novel therapeutical approach for improving the appearance of double chin. Furthermore, these treatments would optimally work by novel mechanisms so that the enhanced adverse effects at injection sites will not limit their use. Our studies suggest that RJV001 may fulfill these requirements.
Adipocytes are attached to an extracellular matrix (ECM) that mainly consists of a collagen network, the degradation of which may induce apoptosis of adipocytes, leading to the improvement of the double chin's appearance. Collagenases are enzymes that break the peptide bonds in collagen; collagenase-induced destruction of the collagen network may lead to improvement in the appearance of the double chin.
Rejuven is currently developing RJV001 for improving the appearance of moderate to severe convexity or fullness-associated SMF in adults. RJV001 is a mutant recombinant collagenase of Clostridium histolyticum, which contains one amino acid difference. This amino acid is in the active center and preclinical studies showed that Kcat of RJV001 was significantly lower than that of the wild type enzyme, but Km of RJV001 was close to that of the wild type. Preclinical studies conducted by Rejuven also demonstrated that RJV001 can still effectively induce lipolysis of fat tissue and that the decreased bioactivity may have the benefit of decreased adverse effects.
- Conditions
- Submental Fat (SMF), Double Chin
- Being tested
- RJV001, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RJV001Drug
Subcutaneous injection in the abdomen
PlaceboDrug
The placebo formulation has the same shape, color, and qualitative composition as the RJV001 freeze dried powder, with the exception that RJV001 drug substance has been removed. For each cohort group, a placebo will be injected in a single site in the same area as the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Dosage group A | Experimental | Dosage group A will consist of 6 subjects, 1:1:1 (A1:A2:A3 below):
A1: 0.04 mg/injection; A2: 0.075 mg/injection; A3: 0.15 mg/injection Two subjects will be dosed in the area scheduled for resection with 5 injections of the lowest of the 3 RJV001 test article strengths (i.e., 0.04 mg/injection); the two subjects will also be dosed with a single injection of vehicle in the area scheduled for resection for a total of 6 injections. At the conclusion of a given test article dose group, if tolerated, enrollment will continue to the next higher dose after approval to advance based upon an interim safety review. This same process will be repeated for the 0.075 mg/injection dose with 2 additional subjects. Assuming the interim safety review for the mid dose (i.e., 0.075 mg/injection) is deemed acceptable, the 2 final subjects will be treated with the high dose (0.15 mg/injection). Receives: Drug: RJV001; Drug: Placebo |
| Dosage group B | Experimental | Dosage group B will consist of 3 subjects (if only 1 dose from Dosage group A is well tolerated) or 6 subjects (if 2 doses from Dosage group A are well tolerated), randomized 1:1 (B1:B2 below).
B1: RJV001 Solution for Injection, Dose 1 B2: RJV001 Solution for Injection, Dose 2 Subjects will be dosed with 1 RJV001 test article (i.e., one of the 2 highest concentrations of RJV001 doses that were well tolerated in Dosage group A, referred to as Dose 1 and Dose 2). Up to 13 injections (12 active and 1 vehicle) will be administered in an open label manner in the area scheduled for resection. If tolerated, enrollment will continue to Dosage group C after approval to advance based upon an interim safety review. Receives: Drug: RJV001; Drug: Placebo |
| Dosage group C | Experimental | Dosage group C will consist of 3 subjects (if only 1 dose from dosage group B is well tolerated) or 6 subjects (if 2 doses from Dosage group B are well tolerated), randomized 1:1 (C1:C2 below).
* C1: RJV001 Solution for Injection, Dose 1
* C2: RJV001 Solution for Injection, Dose 2 Subjects will be dosed with 1 RJV001 test article (i.e., one of the 2 highest concentrations of RJV001 doses that were well tolerated in Cohort B, referred to as Dose 1 and Dose 2). Up to 31 injections (30 active and 1 vehicle) will be administered in an open-label manner in the area scheduled for resection. Receives: Drug: RJV001; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local and systemic adverse events following administration of RJV001
- Necrosis
- Thrombosis
- Ischemia
- Gangrene
- Injection site discoloration
- Allergic dermatitis
- Neovascularization
- Nerve injury
- Pain
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start16 Apr 2021
- Primary completion16 Dec 2021
- Study completion16 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Submental Fat (SMF)Studies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rejuven Dermaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Joseph Gimbel, MD, Rejuven Dermaceutical Co., Ltd.
- Investigators
- Joseph Gimbel, M.D., Principal investigator, Arizona Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821648
- Sponsor's protocol ID
- RJV001-PH1-01
- Status last verified
- Jan 2022
- First submitted
- 25 Mar 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asds consumer survey on cosmetic dermatologic procedures: American Society for Dermatological Surgery; 2018. (Available from: https://www.asds.net/Portals/0/PDF/consumer-survey-2018-infographic.pdf.)
Schlessinger J, Weiss SR, Jewell M, Narurkar V, Weinkle S, Gold MH, Bazerkanian E. Perceptions and practices in submental fat treatment: a survey of physicians and patients. Skinmed. 2013 Jan-Feb;11(1):27-31.
PubMed 23540074Mukherjee A. Pharmacology review(s) of xiaflex. 2009.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety, Tolerability, and Clinical Pharmacology of Subcutaneous Rjv001 in Adult Subjects Undergoing Abdominoplasty
- ClinicalTrials.gov ID
- NCT04821648
- Acronym / sponsor ID
- RJV001-PH1-01
- Conditions
- Submental Fat (SMF), Double Chin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Rejuven Dermaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 29 Mar 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.
In this study, we are testing a new drug against submental fat (SMF), which is characterized with the accumulation of fat under the chin that often appears as a "double chin". The 2018 American Society for Dermatologic Surgery Consumer Survey on Cosmetic Dermatologic Procedures indicated that 73% of respondents were bothered by "excess fat under the chin/neck". This condition of loose or sagging skin under the chin may affect facial symmetry and attractiveness, which can lead to social embarrassment and a negative self-image in many patients.
There is an insufficiency in effective drugs against SMF and double chin. Although an injectable small molecule can be used for improvement of double chin, but its side effects are evident and its cost is high. As such, there remains a real need to develop a cost-effective method to improve appearance of SMF and double chin.
Detailed description
The therapies directed against adipocytes represent a novel therapeutical approach for improving the appearance of double chin. Furthermore, these treatments would optimally work by novel mechanisms so that the enhanced adverse effects at injection sites will not limit their use. Our studies suggest that RJV001 may fulfill these requirements.
Adipocytes are attached to an extracellular matrix (ECM) that mainly consists of a collagen network, the degradation of which may induce apoptosis of adipocytes, leading to the improvement of the double chin's appearance. Collagenases are enzymes that break the peptide bonds in collagen; collagenase-induced destruction of the collagen network may lead to improvement in the appearance of the double chin.
Rejuven is currently developing RJV001 for improving the appearance of moderate to severe convexity or fullness-associated SMF in adults. RJV001 is a mutant recombinant collagenase of Clostridium histolyticum, which contains one amino acid difference. This amino acid is in the active center and preclinical studies showed that Kcat of RJV001 was significantly lower than that of the wild type enzyme, but Km of RJV001 was close to that of the wild type. Preclinical studies conducted by Rejuven also demonstrated that RJV001 can still effectively induce lipolysis of fat tissue and that the decreased bioactivity may have the benefit of decreased adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dosage group A | Experimental | Drug: RJV001, Drug: PlaceboDosage group A will consist of 6 subjects, 1:1:1 (A1:A2:A3 below): A1: 0.04 mg/injection; A2: 0.075 mg/injection; A3: 0.15 mg/injection Two subjects will be dosed in the area scheduled for resection with 5 injections of the lowest of the 3 RJV001 test article strengths (i.e., 0.04 mg/injection); the two subjects will also be dosed with a single injection of vehicle in the area scheduled for resection for a total of 6 injections. At the conclusion of a given test article dose group, if tolerated, enrollment will continue to the next higher dose after approval to advance based upon an interim safety review. This same process will be repeated for the 0.075 mg/injection dose with 2 additional subjects. Assuming the interim safety review for the mid dose (i.e., 0.075 mg/injection) is deemed acceptable, the 2 final subjects will be treated with the high dose (0.15 mg/injection). |
| Dosage group B | Experimental | Drug: RJV001, Drug: PlaceboDosage group B will consist of 3 subjects (if only 1 dose from Dosage group A is well tolerated) or 6 subjects (if 2 doses from Dosage group A are well tolerated), randomized 1:1 (B1:B2 below). B1: RJV001 Solution for Injection, Dose 1 B2: RJV001 Solution for Injection, Dose 2 Subjects will be dosed with 1 RJV001 test article (i.e., one of the 2 highest concentrations of RJV001 doses that were well tolerated in Dosage group A, referred to as Dose 1 and Dose 2). Up to 13 injections (12 active and 1 vehicle) will be administered in an open label manner in the area scheduled for resection. If tolerated, enrollment will continue to Dosage group C after approval to advance based upon an interim safety review. |
| Dosage group C | Experimental | Drug: RJV001, Drug: PlaceboDosage group C will consist of 3 subjects (if only 1 dose from dosage group B is well tolerated) or 6 subjects (if 2 doses from Dosage group B are well tolerated), randomized 1:1 (C1:C2 below). * C1: RJV001 Solution for Injection, Dose 1 * C2: RJV001 Solution for Injection, Dose 2 Subjects will be dosed with 1 RJV001 test article (i.e., one of the 2 highest concentrations of RJV001 doses that were well tolerated in Cohort B, referred to as Dose 1 and Dose 2). Up to 31 injections (30 active and 1 vehicle) will be administered in an open-label manner in the area scheduled for resection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is a male or non-pregnant female 18-65 years of age.
- Subject has provided written informed consent.
- Females must be post-menopausal , surgically sterile , or use an effective method of birth control. , Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Screening and Visit 2/Baseline.
- Subject is scheduled on a specific date to undergo abdominoplasty and meets all pre-operative requirements, in the opinion of the investigator.
- Subject is willing to undergo test article injections as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
Key exclusion criteria (10 listed)
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject has a significant active systemic or localized abdominal infection.
- Subject has any medical condition that affects clotting and/or platelet function (e.g., thromboembolic disease, clotting factor deficiencies such as hemophilia).
- Subject is taking any medications that affect clotting and/or platelet function. This includes, but is not limited to, nonsteroidal anti-inflammatory medications (including low dose aspirin for prophylaxis), heparin (including low molecular weight heparin), Coumadin, and factor Xa agents such as Clopidogrel bisulfate (Plavix) and apixaban (Eliquis), etc. The use of such medications is precluded within 7 days prior to Visit 2/Baseline.
- Subject is immunocompromised, in the opinion of the investigator, based on their medical condition (e.g., positive for human immunodeficiency virus, malignancy), medication use, or other factors.
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 |
|---|---|---|
| RJV001Subcutaneous injection in the abdomen | Drug | Dosage group A, Dosage group B, Dosage group C |
| PlaceboThe placebo formulation has the same shape, color, and qualitative composition as the RJV001 freeze dried powder, with the exception that RJV001 drug substance has been removed. For each cohort group, a placebo will be injected in a single site in the same area as the treatment. | Drug | Dosage group A, Dosage group B, Dosage group C |
Primary outcome
Local and systemic adverse events following administration of RJV001
Time frame: 30 minutes
* Necrosis * Thrombosis * Ischemia * Gangrene * Injection site discoloration * Allergic dermatitis * Neovascularization * Nerve injury * Pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Results publicationAsds consumer survey on cosmetic dermatologic procedures: American Society for Dermatological Surgery; 2018. (Available from: https://www.asds.net/Portals/0/PDF/consumer-survey-2018-infographic.pdf.)
- Results publication: PubMed 23540074Schlessinger J, Weiss SR, Jewell M, Narurkar V, Weinkle S, Gold MH, Bazerkanian E. Perceptions and practices in submental fat treatment: a survey of physicians and patients. Skinmed. 2013 Jan-Feb;11(1):27-31.
- Results publicationMukherjee A. Pharmacology review(s) of xiaflex. 2009.
- Individual participant dataSharing planned: No
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.
Joseph Gimbel, M.D. principal investigator
Arizona Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RJV001 in people with Submental Fat (SMF) and Double Chin, run by Rejuven Dermaceutical Co., Ltd. at 1 site in United States.
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 10 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: finished, as of the sponsor's last update on 18 Jan 2022. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Local and systemic adverse events following administration of RJV001 (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04821648, which also lists 3 linked publications.
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 18 Jan 2022.