Aging HandsNCT01004107
Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation
A study testing Radiesse Injectable Dermal Filler in people with Aging Hands, run by Merz North America, Inc. at 4 sites in Germany.
Trial summary
The purpose of this study is to assess the safety and effectiveness of Radiesse® Injectable Dermal Filler for hand treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging Hands
- What is being tested?
- Radiesse Injectable Dermal Filler
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 4 sitesGermany
- Study dates
- Oct 2008to Apr 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has right and left hands with a rating of 3 or 4 on the Busso Hand Volume Severity Scale (BHVSS) as determined by the treating physician
- Signs a written informed consent
- Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through 12 month follow up
- Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits
Who cannot join
- Has history of hypertropic scarring
- Has a known bleeding disorder or receiving medication that will increase the risk of bleeding as the result of injection
- Has a known hypersensitivity to any of the components of Radiesse or local anesthesia
- Has used predefined products or treatments on the dorsum of the hand within last 4 weeks or intends to use during study
- Has had any dermal fillers or surgery in the dorsum of the hand
- Is a female of child bearing potential and not using medically effective birth control or is pregnant or lactating
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Merz Investigative Site #001
Munich
Merz Investigative Site #002
Munich
Merz Investigative Site #003
Munich
Merz Investigative Site #004
Munich
About this study
Official title: Phase 4, Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation
The purpose of this study is to assess the safety and effectiveness of Radiesse® Injectable Dermal Filler for hand treatment.
Read the detailed description
This is a prospective, randomized, masked, controlled study to investigate the effectiveness of Radiesse® Dermal Filler for hand treatment.
This is a prospective, randomized, masked, controlled study to investigate the effectiveness of Radiesse® Dermal Filler for hand treatment, comprised of a 3-month main study followed by an open-label extension (OLEX) study through 12 months. At 3 months, untreated controls received Radiesse Dermal Filler for hand treatment and were followed for the remainder of the study. All study subjects were eligible for retreatment 6 months after initial treatment, and all subjects were followed through 12 months from study enrollment in the OLEX.
- Conditions
- Aging Hands
- Being tested
- Radiesse Injectable Dermal Filler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiesse Injectable Dermal FillerDevice
Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier
| Study group | Role | What they receive |
|---|---|---|
| Radiesse Injectable Dermal Filler | Experimental | Device: Radiesse Injectable Dermal Filler Receives: Device: Radiesse Injectable Dermal Filler |
| Delayed Treatment | Active comparator | Cross over to treatment with Radiesse Injectable Dermal Filler at 3 Months Receives: Device: Radiesse Injectable Dermal Filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by hand, among treated subjects and untreated controls. Ratings were completed by three, blinded evaluators. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.
Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:
4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;
1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
Measured: 3 months from baseline
≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by hand, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.
Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:
4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;
1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
Measured: 3 months from baseline
≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject
To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by subject, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.
Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:
4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;
1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
Measured: 3 months from baseline
Secondary outcomes (14)
Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects. Ratings were completed by three, blinded evaluators. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.
Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:
4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;
1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
Measured: 3, 6, 9, and 12 months from baseline
≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3, 6, 9 and 12 months, by hand, among treated subjects. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.
Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:
4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;
1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
Measured: 3, 6, 9, and 12 months from baseline
≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject
To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3, 6, 9 and 12 months, by subject, among treated subjects. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score.
Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows:
4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest;
1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
Measured: 3, 6, 9, and 12 months from baseline
Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group and Untreated Controls Only
To evaluate the efficacy of Radiesse Injectable Dermal Filler for hand treatment as measured by a Global Aesthetic Improvement Scale (GAIS), by hand, as completed by three, blinded evaluators.
Measured: 3 months from baseline
Global Aesthetic Improvement Scale (GAIS) Ratings of at Least "Improved" Among the Original Treatment Group Only
Effectiveness was measured by evaluating changes in hand appearance, by subject, using the GAIS completed by three, blinded evaluators
Measured: 3 months from baseline
Global Aesthetic Improvement Scale (GAIS) Ratings, by Hand
To evaluate the efficacy of Radiesse for hand treatment as measured by Global Aesthetic Improvement Scale (GAIS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects. Ratings were completed by three, blinded evaluators.
Measured: 3, 6, 9, and 12 months from baseline
Global Aesthetic Improvement Scale (GAIS) Ratings of at Least "Improved" Over Study
Effectiveness was measured by evaluating changes in hand appearance, by subject, between baseline and 3, 6, 9 and 12 months, by subject, among treated subjects using the GAIS completed by three, blinded evaluators
Measured: 3, 6, 9, and 12 months from baseline
Physician Satisfaction Evaluation
Effectiveness was measured by evaluating level of satisfaction in subject's hand appearance among physicians between baseline and 3, 6, 9 and 12 months, by subject
Measured: 3, 6, 9, and 12 months from baseline
Patient Satisfaction Evaluation
Effectiveness was measured by evaluating level of satisfaction in subject's hand appearance among subjects between baseline and 3, 6, 9 and 12 months
Measured: 3, 6, 9, and 12 months from baseline
Patient Satisfaction Evaluation: Likelihood to Return for Future Radiesse Treatments
Effectiveness was measured by evaluating subject's likelihood of return for additional Radiesse hand treatments at 3, 6, 9 and 12 months
Measured: 3, 6, 9, and 12 months from baseline
Mean Hand Function Rating During Prior Week
Effectiveness was measured by evaluating subject's hand function during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline, by hand. Questions were as follows and were graded by subject as 1 = very good, 2 = good, 3 = fair, 4 = poor, and 5 = very poor:
- Overall, how well did you hand work?
- How well did your fingers move?
- How well did your wrist move?
- How was the strength in your hand?
- How was the sensation (feeling) in your hand?
Measured: Baseline and 3, 6, 9, and 12 months post-treatment
Difficulty Performing Activities During Prior Week
Effectiveness was measured by evaluating subject's difficulty in performing routine activities during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline, by hand. Activities were as follows and were graded by subject as 1 = not at all difficult, 2 = a little difficult, 3 = somewhat difficult, 4 = moderately difficult, and 5 = very difficult:
- Turn a knob
- Pick up a coin
- Hold a glass of water
- Turn a key in a lock
- Hold a frying pan
Measured: Baseline and 3, 6, 9, and 12 months post-treatment
Difficulty Performing Activities During Prior Week, Both Hands
Effectiveness was measured by evaluating subject's difficulty in performing routine activities, that require both hands, during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline. Activities were as follows and were graded by subject as 1 = not at all difficult, 2 = a little difficult, 3 = somewhat difficult, 4 = moderately difficult, and 5 = very difficult:
- Open a jar
- Button a shirt / blouse
- Eat with a knife and fork
- Carry a grocery bag
- Wash dishes
- Wash your hair
- Tie shoelaces / knots
Measured: Baseline and 3, 6, 9, and 12 months post-treatment
Normal Work During Prior Week Evaluation
Effectiveness was measured by evaluating subject's ability to work normally, during the prior week according to a 5-point Michigan Hand Outcomes Questionnaire (MHOQ) scale at baseline and 3, 6, 9, and 12 months post-baseline. Activities were as follows and were graded by subject as 1 = always, 2 = often, 3 = sometimes, 4 = rarely, and 5 = never:
- How often were you unable to do your work because of problems with your hand(s) / wrist(s)?
- How often did you have to shorten your work day because of problems with your hand(s) / wrist(s)?
- How often did you have to take it easy at your work because of problems with your hand(s) / wrist(s)?
- How often did you accomplish less in your work because of problems with your hand(s) / wrist(s)?
- How often did you take longer to do tasks in your work because of problems with your hand(s) / wrist(s)?
Measured: Baseline and 3, 6, 9, and 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startOct 2008
- Primary completionMar 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aging HandsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004107
- Sponsor's protocol ID
- P0508332
- Status last verified
- Sep 2017
- First submitted
- 27 Oct 2009
- Last updated
- 13 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Busso M,et al. Multi-center Randomized Trial Assessing the Effectiveness and Safety of Calcium Hydroxlapatite For Hand Rejuvenation. Derm Surg 2010; 36:790-797
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4, Evaluation of Radiesse® Dermal Filler for Hand Rejuvenation
- ClinicalTrials.gov ID
- NCT01004107
- Acronym / sponsor ID
- P0508332
- Conditions
- Aging Hands
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 29 Oct 2009 (estimated)
- Results
- Posted 13 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and effectiveness of Radiesse® Injectable Dermal Filler for hand treatment.
Detailed description
This is a prospective, randomized, masked, controlled study to investigate the effectiveness of Radiesse® Dermal Filler for hand treatment.
This is a prospective, randomized, masked, controlled study to investigate the effectiveness of Radiesse® Dermal Filler for hand treatment, comprised of a 3-month main study followed by an open-label extension (OLEX) study through 12 months. At 3 months, untreated controls received Radiesse Dermal Filler for hand treatment and were followed for the remainder of the study. All study subjects were eligible for retreatment 6 months after initial treatment, and all subjects were followed through 12 months from study enrollment in the OLEX.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiesse Injectable Dermal Filler | Experimental | Device: Radiesse Injectable Dermal FillerDevice: Radiesse Injectable Dermal Filler |
| Delayed Treatment | Active comparator | Device: Radiesse Injectable Dermal FillerCross over to treatment with Radiesse Injectable Dermal Filler at 3 Months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has right and left hands with a rating of 3 or 4 on the Busso Hand Volume Severity Scale (BHVSS) as determined by the treating physician
- Signs a written informed consent
- Understands and accepts the obligation not to receive any other procedures in the dorsum of the hands through 12 month follow up
- Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits
Key exclusion criteria (6 listed)
- Has history of hypertropic scarring
- Has a known bleeding disorder or receiving medication that will increase the risk of bleeding as the result of injection
- Has a known hypersensitivity to any of the components of Radiesse or local anesthesia
- Has used predefined products or treatments on the dorsum of the hand within last 4 weeks or intends to use during study
- Has had any dermal fillers or surgery in the dorsum of the hand
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 |
|---|---|---|
| Radiesse Injectable Dermal FillerCalcium hydroxylapatite particles suspended in an aqueous-based gel carrier | Device | Delayed Treatment, Radiesse Injectable Dermal Filler |
Primary outcome
Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
Time frame: 3 months from baseline
To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by hand, among treated subjects and untreated controls. Ratings were completed by three, blinded evaluators. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
Time frame: 3 months from baseline
To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by hand, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject
Time frame: 3 months from baseline
To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Busso Hand Volume Severity Scale (BHVSS) between baseline and 3 months, by subject, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in BHVSS score. Busso Hand Volume Severity Scale (BHVSS) rating definitions are as follows: 4 = All 3 central tendons are fully exposed when hand is at rest; 3 = All 3 central tendons are partially exposed with 1 to 2 tendons fully exposed when hand is at rest; 2 = All 3 central tendons are partially exposed when hand is at rest; 1 = One or 2 central tendons are slightly exposed when hand is at rest; and 0 = No tendons exposed when hand is at rest.
14 secondary outcomes
Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
Time frame: 3, 6, 9, and 12 months from baseline
≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Hand
Time frame: 3, 6, 9, and 12 months from baseline
≥ 1-point Change on Busso Hand Volume Severity Scale (BHVSS), by Subject
Time frame: 3, 6, 9, and 12 months from baseline
Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group and Untreated Controls Only
Time frame: 3 months from baseline
Global Aesthetic Improvement Scale (GAIS) Ratings of at Least "Improved" Among the Original Treatment Group Only
Time frame: 3 months from baseline
Global Aesthetic Improvement Scale (GAIS) Ratings, by Hand
Time frame: 3, 6, 9, and 12 months from baseline
Global Aesthetic Improvement Scale (GAIS) Ratings of at Least "Improved" Over Study
Time frame: 3, 6, 9, and 12 months from baseline
Physician Satisfaction Evaluation
Time frame: 3, 6, 9, and 12 months from baseline
Patient Satisfaction Evaluation
Time frame: 3, 6, 9, and 12 months from baseline
Patient Satisfaction Evaluation: Likelihood to Return for Future Radiesse Treatments
Time frame: 3, 6, 9, and 12 months from baseline
Mean Hand Function Rating During Prior Week
Time frame: Baseline and 3, 6, 9, and 12 months post-treatment
Difficulty Performing Activities During Prior Week
Time frame: Baseline and 3, 6, 9, and 12 months post-treatment
Difficulty Performing Activities During Prior Week, Both Hands
Time frame: Baseline and 3, 6, 9, and 12 months post-treatment
Normal Work During Prior Week Evaluation
Time frame: Baseline and 3, 6, 9, and 12 months post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundBusso M,et al. Multi-center Randomized Trial Assessing the Effectiveness and Safety of Calcium Hydroxlapatite For Hand Rejuvenation. Derm Surg 2010; 36:790-797
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiesse Injectable Dermal Filler in people with Aging Hands, run by Merz North America, Inc. at 4 sites in Germany.
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 6 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 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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?
Yes. Results are posted in the registry (first posted 13 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change on Busso Hand Volume Severity Scale (BHVSS), by Hand (time frame: 3 months from baseline). 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?
On the ClinicalTrials.gov record for NCT01004107, which also lists 1 linked publication.
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 13 Jul 2018; AzTrials last refreshed its copy on 7 Nov 2026.