Volume Loss to Dorsum of HandsNCT02454088
A Single-Center Investigator-Initiated Evaluator-Bilateral-Comparison Pilot Study of Injectable Calcium Hydroxylapatite With and Without Triamcinolone Acetate for the Treatment of Volume Loss to Dorsum Areas of the Hands
A study testing Calcium Hydroxylapatite and Triamcinolone acetate in people with Volume Loss to Dorsum of Hands, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
Trial summary
This will be a single-center, investigator-initiated, double-blinded, randomized, bilateral-comparison pilot study of injectable Calcium hydroxylapatite with and without Triamcinolone acetate for the treatment of volume loss to the dorsum areas of the hands. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Volume Loss to Dorsum of Hands
- What is being tested?
- Calcium Hydroxylapatite and Triamcinolone acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Nov 2016
- Phase
- Interventional
- 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
Who may be able to join
- Cutaneous and soft tissue atrophy in the dorsum of both hands, as indicated by the Merz Validated Hand Grading Scale score of 2, 3 or 4.
- Males or females in good general health who are 22 years of age or older.
- Must be willing to give and sign an informed consent form and photographic release form.
- Subject is planning re-volumizing rejuvenation treatment to the dorsum area of both hands.
- For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment participation.
- A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.
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- Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g. condoms and spermicide), abstinence and/or vasectomies of partner with a documented second acceptable method of birth control, should the subject become sexually active.
- Negative urine pregnancy test results at the time of study entry (if applicable).
- Must be willing to comply with study dosing and complete the entire course of the study.
Who cannot join
- A subject with any uncontrolled systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
- A Subject that is currently using systemic steroids.
- A subject with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- A subject with history of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis).
- A subject with an active bacterial, fungal, or viral infection in the treatment area.
- A subject with an active systemic fungal infection.
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- A subject with a prior history of an allergy to any of the products or medications being used in the study.
- A subject planning any other cosmetic procedure to the study area during the study period, other than the treatments that will be performed by the investigator.
- A subject with a history of previous fat transfer or injectable poly-l-lactic acid to the study area within the past five years.
- A subject with a previous history of calcium hydroxylapatite to the treatment area within the past year.
- A subject with a previous history of ablative laser surgery to the treatment area within the past year.
- A female subject who is pregnant, nursing an infant or planning a pregnancy during the study.
- Subjects with known autoimmune disease or compromised immune systems i.e. HIV, AIDS or current chemotherapy.
- Subjects with known bleeding disorder or is receiving medication that will likely increase the risk of bleeding as the result of injection per investigator discretion.
- Subjects with a history hypertrophic scarring.
- Subjects with a cancerous or precancerous lesion, or unhealed wound in the treatment area.
- Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cosmetic Laser Dermatology
San Diego, California, 92121
About this study
This will be a single-center, investigator-initiated, double-blinded, randomized, bilateral-comparison pilot study of injectable Calcium hydroxylapatite with and without Triamcinolone acetate for the treatment of volume loss to the dorsum areas of the hands.
- Conditions
- Volume Loss to Dorsum of Hands
- Being tested
- Calcium Hydroxylapatite and Triamcinolone acetate, Calcium Hydroxylapatite and Placebo
- Keywords
- Volume, Hands, Filler, Radiesse, Calcium hydroxylapatite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Hydroxylapatite and Triamcinolone acetateOther
Combination Therapy Triamcinolone acetate and Calcium Hydroxylapatite
Calcium Hydroxylapatite and PlaceboDevice
Calcium Hydroxylapatite and Placebo
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone acetate | Active comparator | Injection of Calcium hydroxylapatite with Triamcinolone acetate Receives: Other: Calcium Hydroxylapatite and Triamcinolone acetate |
| Placebo | Placebo comparator | Injection of Calcium hydroxylapatite with a placebo Receives: Device: Calcium Hydroxylapatite and Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Analysis (Merz Validated Hand Grading Score)
The primary analyses of efficacy will be based on the change from Baseline through Day 360 for assessment (based on the Merz Validated Hand Grading Score).
Measured: Through day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volume Loss to Dorsum of 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Collaborators
- Merz North America, Inc.
- Responsible party
- Sponsor
- Investigators
- Mitchel P Goldman, MD, Principal investigator, Cosmetic Laser Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454088
- Sponsor's protocol ID
- RAD-2010
- Status last verified
- Feb 2017
- First submitted
- 13 May 2015
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Investigator-Initiated Evaluator-Bilateral-Comparison Pilot Study of Injectable Calcium Hydroxylapatite With and Without Triamcinolone Acetate for the Treatment of Volume Loss to Dorsum Areas of the Hands
- ClinicalTrials.gov ID
- NCT02454088
- Acronym / sponsor ID
- RAD-2010
- Conditions
- Volume Loss to Dorsum of Hands
- Keywords
- Volume, Hands, Filler, Radiesse, Calcium hydroxylapatite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Collaborators
- Merz North America, Inc.
- Study start
- May 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 27 May 2015 (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.
This will be a single-center, investigator-initiated, double-blinded, randomized, bilateral-comparison pilot study of injectable Calcium hydroxylapatite with and without Triamcinolone acetate for the treatment of volume loss to the dorsum areas of the hands.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone acetate | Active comparator | Other: Calcium Hydroxylapatite and Triamcinolone acetateInjection of Calcium hydroxylapatite with Triamcinolone acetate |
| Placebo | Placebo comparator | Device: Calcium Hydroxylapatite and PlaceboInjection of Calcium hydroxylapatite with a placebo |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Cutaneous and soft tissue atrophy in the dorsum of both hands, as indicated by the Merz Validated Hand Grading Scale score of 2, 3 or 4.
- Males or females in good general health who are 22 years of age or older.
- Must be willing to give and sign an informed consent form and photographic release form.
- Subject is planning re-volumizing rejuvenation treatment to the dorsum area of both hands.
- For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment participation.
Key exclusion criteria (17 listed)
- A subject with any uncontrolled systemic disease. A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
- A Subject that is currently using systemic steroids.
- A subject with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- A subject with history of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis).
- A subject with an active bacterial, fungal, or viral infection in the treatment area.
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 |
|---|---|---|
| Calcium Hydroxylapatite and Triamcinolone acetateCombination Therapy Triamcinolone acetate and Calcium Hydroxylapatite | Other | Triamcinolone acetate |
| Calcium Hydroxylapatite and PlaceboCalcium Hydroxylapatite and Placebo | Device | Placebo |
Primary outcome
Efficacy Analysis (Merz Validated Hand Grading Score)
Time frame: Through day 360
The primary analyses of efficacy will be based on the change from Baseline through Day 360 for assessment (based on the Merz Validated Hand Grading Score).
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 1 Mar 2017.
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.
Mitchel P Goldman, MD principal investigator
Cosmetic Laser Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium Hydroxylapatite and Triamcinolone acetate in people with Volume Loss to Dorsum of Hands, run by Goldman, Butterwick, Fitzpatrick and Groff 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 9 inclusion and 17 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 1 Mar 2017. 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. Some participants in this study may receive a placebo. 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?
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 Analysis (Merz Validated Hand Grading Score) (time frame: Through day 360). 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 Mar 2017.