Nasolabial FoldsPhase 3NCT01060943
An Efficacy and Safety Study of TheraFill® Versus KOKEN for 3 Months on Nasolabial Folds
A Phase 3 study testing KOKEN and Atelocollagen Filler in people with Nasolabial Folds, run by Cellontech Co., Ltd. at 1 site in South Korea.
Trial summary
Investigational Device : TheraFill® (Atelocollagen Dermal Filler) Title : A Randomized, Multicenter, Prospective and Paired Comparison of the Efficacy and Safety of TheraFill® versus KOKEN for 3months on Nasolabial Folds Sites and investigators : The Catholic University of Korea. Kangnam St. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- KOKEN and Atelocollagen Filler
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2008to Jan 2009
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those who agreed to this treatment and signed the Informed Consent Form
- Those who are 20 years old or more and desire to take correction of nasolabial folds
- Those who have an intention of refraining from other cosmetic treatment(other filler injection, laser or chemical peeling, Botox injection or wrinkle reduction) during the clinical study period
- Those whose Wrinkle Severity Rating Scale (WSRS) is more than 2 points at least
Who cannot join
- Subjects or their families who currently have or have the history of autoimmune disease or collagen vascular disease
- Those who had the history of anaphylactic response
- Those who are sensitive to implant
- Those who are sensitive to lidocaine or other amide anesthesia
- Those who are sensitive to porcine protein
- Those who are sensitive to control device
Show all 10Show fewer
- Those who have taken soft tissue augmentation, laser or cosmetic facial surgery to improve the injection area in 6 months before participation in the clinical study
- Those who are pregnant or lactating, or expect pregnancy
- Those who have inflammatory skin disease on the injection area
- Those who are judged by the subinvestigator to be improper for this study due to mental disease etc.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kangnam St.Mary's Hospital of Catholic University
Seoul, Seo-cho
About this study
Official title: A Randomized, Multicenter, Prospective, Paired Comparison of the Efficacy and Safety of TheraFill® Versus KOKEN for 3 Months on Nasolabial Folds
- Investigational Device : TheraFill® (Atelocollagen Dermal Filler)
- Title : A Randomized, Multicenter, Prospective and Paired Comparison of the Efficacy and Safety of TheraFill® versus KOKEN for 3months on Nasolabial Folds
- Sites and investigators :
- The Catholic University of Korea. Kangnam St. Mary's Hospital (#505, Banpo-dong, Seocho-gu, SEOUL)
- The Catholic Univ. of Korea Holy Family Hospital (#2, Sosa-dong, Wonmi-gu, Bucheon-si, Gyeonggi-do)
- Objective : To compare the non-inferiority of TheraFill® with KOKEN for evaluation of the efficacy and safety on Nasolabial Folds for 3months
- Clinical Study Method : Seventy-three subjects who agree to voluntarily participate in the clinical study are randomized to treatment with TheraFill (porcine atelocollagen filler) and KOKEN (bovine atelocollagen filler) in the contralateral fold(NFL). The subjects shall regularly visit the hospital 5 times or more and if subjects take touch-up treatments, the number of visit times will be increased. Treatments shall be repeated at 2 weeks intervals, as required, to achieve "Optimal cosmetic result". Outcomes shall be evaluated by blinded investigators, investigators and subjects at 2,4 and 12 weeks after baseline.
- Subjects : The target number of subjects is 62subjects, and 73 subjects are selected in the screening period in consideration of 15% of dropout rate.
Read the detailed description
- Evaluation Criteria And Analysis Method :
- Efficacy - Evaluate total 3 times : 2, 4 and 12 weeks after last injection. In efficacy evaluation data, for difference in WSRS improvement ratio, normality test on the ratio is used, and for the other evaluation variables, statistical hypothesis test is conducted by using t-test, Wilcoxon rank-sum test, Chi-square test, and ANOVA for repeatedly measured data according to the nature of data.
- Wrinkle Severity Rating System - It is ranged from 1 point (absent) to 5 points (extreme), and WSRS scores are compared baseline(pre-injection period) with every visits.
- Evaluation of subject's improvement - It is ranged from 1 point (worse) to 5 points (much improved). A degree of improvement to which the subject decides upon every visit is evaluated, compared to the screening period (baseline).
- Evaluation of investigator's improvement - It is ranged from 1 point (worse) to 5 points (much improved). A degree of improvement to which the investigator decides upon every visit is evaluated, compared to the screening period (baseline).
- Safety The analysis of safety evaluation data is conducted through descriptive statistics using the causal relationship between outbreak frequency and the devices .
- Subjective adverse events : Uncomfortable sense after TheraFill® injection
- Objective adverse events : Investigator shall observe and evaluate adverse events such as edema, redness, tenderness, pain, bruise, itching, nodule and others at injected site after injection
- Evidence : 1. Photographs At screening period, injection, 2, 4 and 12 weeks after injection and upon an adverse event, the photograph results of the front and side shall be attached to the Case Report Form and utilized as objective reference data.
- Conditions
- Nasolabial Folds
- Being tested
- KOKEN, Atelocollagen Filler
- Keywords
- injectable collagen filler, correction of wrinkles and folds, enrolled : 73, withdrawal : 4, ongoing : 0, completed : 69
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KOKENDevice
Also called KOKEN ATELOCOLLAGEN FILLER
atelocollagen filler
1ml pre-filled syringe. 3% atelocollagen is dissolved in PBS. Inject several times every 2 weeks or more weeks. Total amount should be limited up to 25ml per an year.
Atelocollagen FillerDevice
Also called TheraFill ATELOCOLLAGEN FILLER
1ml pre-filled syringe. 3% atelocollagen is dissolved in PBS. Inject several times every 2 weeks or more weeks. Total amount should be limited up to 25ml per an year.
| Study group | Role | What they receive |
|---|---|---|
| KOKEN(collagen) | Active comparator | atelocollagen filler Receives: Device: KOKEN |
| TheraFill | Experimental | atelocollagen filler Receives: Device: Atelocollagen Filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Wrinkle Severity Rating Scale - Primary endpoint
Measured: At screening period, 2, 4 and 12 weeks after last injection
Efficacy: An assessment of the degree of improvement based on the judgement of patients
Measured: At screening period, 2, 4 and 12 weeks after last injection
Efficacy: An assessment of the degree of improvement based on the judgement of the Investigators
Measured: At screening period, 2, 4 and 12 weeks after last injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startMay 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial FoldsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellontech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jong Won Lee, Ph.D, Principal investigator, St.Mary's Hospital of Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060943
- Sponsor's protocol ID
- 01TRF
- Status last verified
- Feb 2010
- First submitted
- 21 Jan 2010
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Prospective, Paired Comparison of the Efficacy and Safety of TheraFill® Versus KOKEN for 3 Months on Nasolabial Folds
- ClinicalTrials.gov ID
- NCT01060943
- Acronym / sponsor ID
- 01TRF
- Conditions
- Nasolabial Folds
- Keywords
- injectable collagen filler, correction of wrinkles and folds, enrolled : 73, withdrawal : 4, ongoing : 0, completed : 69
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Cellontech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 2 Feb 2010 (estimated)
- 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.
- Investigational Device : TheraFill® (Atelocollagen Dermal Filler)
- Title : A Randomized, Multicenter, Prospective and Paired Comparison of the Efficacy and Safety of TheraFill® versus KOKEN for 3months on Nasolabial Folds
- Sites and investigators :
- The Catholic University of Korea. Kangnam St. Mary's Hospital (#505, Banpo-dong, Seocho-gu, SEOUL)
- The Catholic Univ. of Korea Holy Family Hospital (#2, Sosa-dong, Wonmi-gu, Bucheon-si, Gyeonggi-do)
- Objective : To compare the non-inferiority of TheraFill® with KOKEN for evaluation of the efficacy and safety on Nasolabial Folds for 3months
- Clinical Study Method : Seventy-three subjects who agree to voluntarily participate in the clinical study are randomized to treatment with TheraFill (porcine atelocollagen filler) and KOKEN (bovine atelocollagen filler) in the contralateral fold(NFL). The subjects shall regularly visit the hospital 5 times or more and if subjects take touch-up treatments, the number of visit times will be increased. Treatments shall be repeated at 2 weeks intervals, as required, to achieve "Optimal cosmetic result". Outcomes shall be evaluated by blinded investigators, investigators and subjects at 2,4 and 12 weeks after baseline.
- Subjects : The target number of subjects is 62subjects, and 73 subjects are selected in the screening period in consideration of 15% of dropout rate.
Detailed description
- Evaluation Criteria And Analysis Method :
- Efficacy - Evaluate total 3 times : 2, 4 and 12 weeks after last injection. In efficacy evaluation data, for difference in WSRS improvement ratio, normality test on the ratio is used, and for the other evaluation variables, statistical hypothesis test is conducted by using t-test, Wilcoxon rank-sum test, Chi-square test, and ANOVA for repeatedly measured data according to the nature of data.
- Wrinkle Severity Rating System - It is ranged from 1 point (absent) to 5 points (extreme), and WSRS scores are compared baseline(pre-injection period) with every visits.
- Evaluation of subject's improvement - It is ranged from 1 point (worse) to 5 points (much improved). A degree of improvement to which the subject decides upon every visit is evaluated, compared to the screening period (baseline).
- Evaluation of investigator's improvement - It is ranged from 1 point (worse) to 5 points (much improved). A degree of improvement to which the investigator decides upon every visit is evaluated, compared to the screening period (baseline).
- Safety The analysis of safety evaluation data is conducted through descriptive statistics using the causal relationship between outbreak frequency and the devices .
- Subjective adverse events : Uncomfortable sense after TheraFill® injection
- Objective adverse events : Investigator shall observe and evaluate adverse events such as edema, redness, tenderness, pain, bruise, itching, nodule and others at injected site after injection
- Evidence : 1. Photographs At screening period, injection, 2, 4 and 12 weeks after injection and upon an adverse event, the photograph results of the front and side shall be attached to the Case Report Form and utilized as objective reference data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KOKEN(collagen) | Active comparator | Device: KOKENatelocollagen filler |
| TheraFill | Experimental | Device: Atelocollagen Filleratelocollagen filler |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Those who agreed to this treatment and signed the Informed Consent Form
- Those who are 20 years old or more and desire to take correction of nasolabial folds
- Those who have an intention of refraining from other cosmetic treatment(other filler injection, laser or chemical peeling, Botox injection or wrinkle reduction) during the clinical study period
- Those whose Wrinkle Severity Rating Scale (WSRS) is more than 2 points at least
Key exclusion criteria (10 listed)
- Subjects or their families who currently have or have the history of autoimmune disease or collagen vascular disease
- Those who had the history of anaphylactic response
- Those who are sensitive to implant
- Those who are sensitive to lidocaine or other amide anesthesia
- Those who are sensitive to porcine protein
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 |
|---|---|---|
| KOKENAlso: KOKEN ATELOCOLLAGEN FILLERatelocollagen filler 1ml pre-filled syringe. 3% atelocollagen is dissolved in PBS. Inject several times every 2 weeks or more weeks. Total amount should be limited up to 25ml per an year. | Device | KOKEN(collagen) |
| Atelocollagen FillerAlso: TheraFill ATELOCOLLAGEN FILLER1ml pre-filled syringe. 3% atelocollagen is dissolved in PBS. Inject several times every 2 weeks or more weeks. Total amount should be limited up to 25ml per an year. | Device | TheraFill |
Primary outcome
Efficacy: Wrinkle Severity Rating Scale - Primary endpoint
Time frame: At screening period, 2, 4 and 12 weeks after last injection
Efficacy: An assessment of the degree of improvement based on the judgement of patients
Time frame: At screening period, 2, 4 and 12 weeks after last injection
Efficacy: An assessment of the degree of improvement based on the judgement of the Investigators
Time frame: At screening period, 2, 4 and 12 weeks after last injection
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 2 Feb 2010.
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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.
Jong Won Lee, Ph.D principal investigator
St.Mary's Hospital of Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KOKEN and Atelocollagen Filler in people with Nasolabial Folds, run by Cellontech Co., Ltd. at 1 site in South Korea.
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 4 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 2 Feb 2010. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Efficacy: Wrinkle Severity Rating Scale - Primary endpoint (time frame: At screening period, 2, 4 and 12 weeks after last injection). The study lists 3 primary outcomes in all. 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 2 Feb 2010.