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

NCT ID: NCT02454088

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-11-30

Brief 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.

Conditions

Volume Loss to Dorsum of Hands

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Triamcinolone acetate

Injection of Calcium hydroxylapatite with Triamcinolone acetate

Group Type: ACTIVE_COMPARATOR

Calcium Hydroxylapatite and Triamcinolone acetate

Intervention Type: OTHER

Combination Therapy Triamcinolone acetate and Calcium Hydroxylapatite

Placebo

Injection of Calcium hydroxylapatite with a placebo

Group Type: PLACEBO_COMPARATOR

Calcium Hydroxylapatite and Placebo

Intervention Type: DEVICE

Calcium Hydroxylapatite and Placebo

Interventions

Calcium Hydroxylapatite and Triamcinolone acetate

Combination Therapy Triamcinolone acetate and Calcium Hydroxylapatite

Intervention Type: OTHER

Calcium Hydroxylapatite and Placebo

Calcium Hydroxylapatite and Placebo

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Males or females in good general health who are 22 years of age or older.

3. Must be willing to give and sign an informed consent form and photographic release form.

4. Subject is planning re-volumizing rejuvenation treatment to the dorsum area of both hands.

5. 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.

6. Negative urine pregnancy test results at the time of study entry (if applicable).

7. Must be willing to comply with study dosing and complete the entire course of the study.

Exclusion Criteria

1. 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.

2. A Subject that is currently using systemic steroids.

3. 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.

4. 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).

5. A subject with an active bacterial, fungal, or viral infection in the treatment area.

6. A subject with an active systemic fungal infection.

7. A subject with a prior history of an allergy to any of the products or medications being used in the study.

8. 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.

9. A subject with a history of previous fat transfer or injectable poly-l-lactic acid to the study area within the past five years.

10. A subject with a previous history of calcium hydroxylapatite to the treatment area within the past year.

11. A subject with a previous history of ablative laser surgery to the treatment area within the past year.

12. A female subject who is pregnant, nursing an infant or planning a pregnancy during the study.

13. Subjects with known autoimmune disease or compromised immune systems i.e. HIV, AIDS or current chemotherapy.

14. 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.

15. Subjects with a history hypertrophic scarring.

16. Subjects with a cancerous or precancerous lesion, or unhealed wound in the treatment area.

17. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merz North America, Inc.

INDUSTRY

Sponsor Role: collaborator

Goldman, Butterwick, Fitzpatrick and Groff

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitchel P Goldman, MD

Role: PRINCIPAL_INVESTIGATOR

Cosmetic Laser Dermatology

Locations

Cosmetic Laser Dermatology

San Diego, California, United States

Countries

United States

Other Identifiers

RAD-2010

Identifier Type: -

Identifier Source: org_study_id