Clinical trial NCT01147172: Safety Study of Cosmetic Tissue Augmentation in People of Color
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkles
Keywords: Nasolabial Folds
Cosmetic
Injectable Dermal Filler
Hyaluronic Acid with Lidocaine
Lead sponsor: Anika Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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)

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Keloid Formation at Site of Injection
timeFrame: 2 Weeks
measure: Keloid Formation at Site of Injection
timeFrame: 6 Weeks
measure: Keloid Formation at Site of Injection
timeFrame: 12 Weeks
measure: Keloid Formation at Site of Injection
timeFrame: 24 Weeks
measure: Pigmentation Changes at Site of Injection
timeFrame: 2 Weeks
measure: Pigmentation Changes at Site of Injection
timeFrame: 6 Weeks
measure: Pigmentation Changes at Site of Injection
timeFrame: 12 Weeks
measure: Pigmentation Changes at Site of Injection
timeFrame: 24 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Vitiligo and Pigmentation Inst of Southern California
state: California
city: Boca Raton
country: United States
facility: Skin Care Research, Inc.
state: Florida
city: Coral Gables
country: United States
facility: Dermatology Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: International Dermatology Research
state: Florida
city: Metairie
country: United States
facility: William Coleman, MD
state: Louisiana
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: New York
country: United States
facility: St Luke's Roosevelt
state: New York
city: Nashville
country: United States
facility: Tenneesee Clinical Research Center
state: Tennessee
city: Austin
country: United States
facility: Derm Research, Inc.
state: Texas
Study officials:
affiliation: Dermatology Research Institute, LLC
name: Frederic Brandt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Practice
name: William P Coleman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tennessee Clinical Research Center
name: Michael Gold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Dermatology Research, Inc.
name: Alicia Barba, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Luke's-Roosevelt Hospital Center
name: Andrew Alexis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Derm Research, Inc.
name: Michael Jarratt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vitiligo & Pigmentation Institute of Southern California
name: Pearl Grimes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skin Care Research, Inc.
name: Marta Rendon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Academic Dermatology Associates
name: Eduardo Tschen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kokelj F, Burnett JW. Treatment of a pigmented lesion induced by a Pelagia noctiluca sting. Cutis. 1990 Jul;46(1):62-4.
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. doi: 10.1097/00004630-199607000-00012.
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. doi: 10.1007/s10103-007-0451-0. Epub 2007 Mar 13.
citation: Tomita Y, Maeda K, Tagami H. Mechanisms for hyperpigmentation in postinflammatory pigmentation, urticaria pigmentosa and sunburn. Dermatologica. 1989;179 Suppl 1:49-53. doi: 10.1159/000248449.