Safety Study of Cosmetic Tissue Augmentation in People of Color

Wrinkles Clinical Trial

Official title:

A Post Approval, Multicenter, Open-Label, Longitudinal, Uncontrolled Safety Study of Cosmetic Tissue Augmentation Product (ELEVESS™) in the Treatment of Nasolabial Folds in People of Color

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147172
• Other study ID #: CTA0701
• Status: Completed
• Phase: N/A
• First received: June 3, 2010
• Last updated: September 15, 2017
• Start date: March 2009
• Est. completion date: August 2010

Study information

• Verified date: September 2017
• Source: Anika Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Elevess is intended for all skin types. However, further study of all soft tissue fillers is needed in people of color because of the increasing use of cosmetic dermal filler products.

This study is designed to evaluate the safety of an injectable hyaluronic acid based dermal filler Elevess (Anika Therapeutics, Inc., Bedford, MA). Safety will be evaluated by incidence and severity of keloid formation and pigmentation changes, and other potential adverse events in people with Fitzpatrick skin types IV, V and VI who have elected to undergo nasolabial fold (NLF) treatment with Elevess.

1. Fitzpatrick Classification of Skin Type as: IV - Burns minimally, always tans well (moderate/light brown skin; Mediterranean, Asian, Hispanic. V - Rarely burns, tans profusely (dark brown/brown skin: Middle eastern, Latin, light skinned Black, Indian) VI - Never burns, (deeply pigmented dark brown to black skin;Black)

Description:

This study is designed to be an open-label, longitudinal, uncontrolled study in a minimum of 100 subjects with Fitzpatrick scale skin type of IV, V or VI at 10 or more U.S. centers who have elected to undergo NLF treatment with intradermal (deep dermal) injection of Elevess. Subjects will be followed for a minimum of 24 weeks with visit assessments at 2, 6, 12 and 24 weeks after the last injection.

Safety: Primary Safety Endpoint assessments will be: 1) keloid formation at the site of injection at 2, 6, 12 and 24 weeks, 2) pigmentation changes at the site of injection compared to adjacent skin at 2, 6, 12 and 24 weeks, and 3) overall adverse events. A subject diary will also be collected.

Effectiveness: No formal effectiveness evaluation will be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Fitzpatrick skin type of IV, V or VI.

• Bilateral nasolabial folds which, in the investigator's judgment, can be corrected with Elevess.

• Age greater or equal to 18 years.

Exclusion Criteria:

• Fitzpatrick skin type of I, II or III.

• Subject has severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.

• Subject has allergies to the components of Elevess: hyaluronic acid, lidocaine, sodium metabisulfite or gram positive bacterial proteins.

• Subject has a history of severe keloids and/or hypertrophic scars.

• Subject has ever received any soft tissue augmentation in any area of the face and subject is unwilling to forgo all other soft tissue augmentation for the duration of the study.

• Subject has received any aesthetic or dermatologic treatments or procedures in any area of the face in the previous 6 months and subject is unwilling to forgo such treatments or procedures for the duration of the study.

• Subject has active facial acne lesions, severe acne scarring or pigmentation disorders at the injection site that might affect clinical assessment of the nasolabial folds.

• Subject has ever received an injection or implant of silicone in any area of the face.

• Subject has received immunosuppressive therapy, chemotherapy, or systemic corticosteroids within the last 3 months.

• Subject has a history of a connective tissue disease.

• Subject is positive for HIV/AIDS or hepatitis C.

• Subject is involved in any other research study involving an investigational product (drug, device or biologic) or a new application of an approved product, within 30 days of screening

Related Conditions & MeSH terms

• Wrinkles

Intervention

Device:
• Elevess
Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	Derm Research, Inc.	Austin	Texas
United States	Skin Care Research, Inc.	Boca Raton	Florida
United States	Dermatology Research Institute, LLC	Coral Gables	Florida
United States	Vitiligo and Pigmentation Inst of Southern California	Los Angeles	California
United States	William Coleman, MD	Metairie	Louisiana
United States	International Dermatology Research	Miami	Florida
United States	Tenneesee Clinical Research Center	Nashville	Tennessee
United States	St Luke's Roosevelt	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Anika Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

Kokelj F, Burnett JW. Treatment of a pigmented lesion induced by a Pelagia noctiluca sting. Cutis. 1990 Jul;46(1):62-4. — View Citation

Linder SA, Mele JA 3rd, Harries T. Chronic hyperpigmentation from a heated mustard compress burn: a case report. J Burn Care Rehabil. 1996 Jul-Aug;17(4):351-2. Review. — View Citation

Royston SL, Wright PA, Widdowson DC, Wareham WJ, Strike PW. Adverse effects reported in epilatory ruby laser treatment. Lasers Med Sci. 2008 Jan;23(1):35-9. Epub 2007 Mar 13. — View Citation

Tomita Y, Maeda K, Tagami H. Mechanisms for hyperpigmentation in postinflammatory pigmentation, urticaria pigmentosa and sunburn. Dermatologica. 1989;179 Suppl 1:49-53. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Keloid Formation at Site of Injection	Percentage of Subjects with keloid formation at the site of injection	2 Weeks
Primary	Keloid Formation at Site of Injection	Percentage of Subjects with keloid formation at the site of injection	6 Weeks
Primary	Keloid Formation at Site of Injection	Percentage of Subjects with keloid formation at the site of injection	12 Weeks
Primary	Keloid Formation at Site of Injection	Percentage of subjects with keloid formation at the site of injection at End of Study	24 Weeks
Primary	Pigmentation Changes at Site of Injection	Percentage of Subjects with pigmentation changes at site of injection	2 Weeks
Primary	Pigmentation Changes at Site of Injection	Percentage of Subjects with pigmentation changes at site of injection	6 Weeks
Primary	Pigmentation Changes at Site of Injection	Percentage of Subjects with pigmentation changes at site of injection	12 Weeks
Primary	Pigmentation Changes at Site of Injection	Percentage of subjects with pigmentation changes at site of injection at End of Study	24 Weeks