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| Name | Class |
|---|---|
| Merz North America, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triamcinolone acetate | Active Comparator | Injection of Calcium hydroxylapatite with Triamcinolone acetate |
|
| Placebo | Placebo Comparator | Injection of Calcium hydroxylapatite with a placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium Hydroxylapatite and Triamcinolone acetate | Other | Combination Therapy Triamcinolone acetate and Calcium Hydroxylapatite |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Through day 360 |
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Inclusion Criteria:
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.
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchel P Goldman, MD | Cosmetic Laser Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cosmetic Laser Dermatology | San Diego | California | 92121 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 20, 2019 | |
| Reset | Mar 13, 2019 | |
| Release | Mar 15, 2019 |
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| Calcium Hydroxylapatite and Placebo | Device | Calcium Hydroxylapatite and Placebo |
|
| Reset | Apr 8, 2019 |
| Release | Apr 30, 2019 |
| Reset | May 21, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 20, 2019 | Mar 13, 2019 | |||
| Mar 15, 2019 | Apr 8, 2019 | |||
| Apr 30, 2019 | May 21, 2019 |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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