WrinklesNCT01147172

Safety Study of Cosmetic Tissue Augmentation in People of Color

A study testing Elevess in people with Wrinkles, run by Anika Therapeutics, Inc. at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Wrinkles
What is being tested?: Elevess
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 9 sitesUnited States
Study dates: Mar 2009to Aug 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 12Show fewer

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

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Academic Dermatology Associates
Albuquerque, New Mexico, 87106
Derm Research, Inc.
Austin, Texas, 78759
Skin Care Research, Inc.
Boca Raton, Florida, 33486
Dermatology Research Institute, LLC
Coral Gables, Florida, 33146
Vitiligo and Pigmentation Inst of Southern California
Los Angeles, California, 90036
William Coleman, MD
Metairie, Louisiana, 70006
International Dermatology Research
Miami, Florida, 33144
Tenneesee Clinical Research Center
Nashville, Tennessee, 37215
St Luke's Roosevelt
New York, New York, 10025

Other trials in United States

About this study

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

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.

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)

Read the 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.

Conditions: Wrinkles
Being tested: Elevess
Keywords: Nasolabial Folds, Cosmetic, Injectable Dermal Filler, Hyaluronic Acid with Lidocaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01147172
Study group	Role	What they receive
Elevess	Experimental	Gel implant (dermal filler) composed of hyaluronan produced by Streptococcus equi (bacterial fermentation) that is cross-linked and suspended in phosphate buffered saline with 0.3% lidocaine HCl and 0.1% sodium metabisulfite Receives: Device: Elevess

What is being measured

The primary outcome is the main question the study is designed to answer.

Keloid Formation at Site of Injection
Percentage of Subjects with keloid formation at the site of injection
Measured: 2 Weeks
Keloid Formation at Site of Injection
Percentage of Subjects with keloid formation at the site of injection
Measured: 6 Weeks
Keloid Formation at Site of Injection
Percentage of Subjects with keloid formation at the site of injection
Measured: 12 Weeks
Keloid Formation at Site of Injection
Percentage of subjects with keloid formation at the site of injection at End of Study
Measured: 24 Weeks
Pigmentation Changes at Site of Injection
Percentage of Subjects with pigmentation changes at site of injection
Measured: 2 Weeks
Pigmentation Changes at Site of Injection
Percentage of Subjects with pigmentation changes at site of injection
Measured: 6 Weeks
Pigmentation Changes at Site of Injection
Percentage of Subjects with pigmentation changes at site of injection
Measured: 12 Weeks
Pigmentation Changes at Site of Injection
Percentage of subjects with pigmentation changes at site of injection at End of Study
Measured: 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Aug 2010

First posted22 Jun 2010 (estimated)
Study startMar 2009
Primary completionDec 2009
Study completionAug 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for WrinklesStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01147172
Sponsor's protocol ID: CTA0701
Status last verified: Sep 2017
First submitted: 3 Jun 2010
Last updated: 17 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Kokelj F, Burnett JW. Treatment of a pigmented lesion induced by a Pelagia noctiluca sting. Cutis. 1990 Jul;46(1):62-4.
PubMed 1974491
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.
PubMed 8844357
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.
PubMed 17431730
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.
PubMed 2550287

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Wrinkles trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01147172
Acronym / sponsor ID: CTA0701
Conditions: Wrinkles
Keywords: Nasolabial Folds, Cosmetic, Injectable Dermal Filler, Hyaluronic Acid with Lidocaine
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Anika Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Dec 2009 (actual)
Study completion: Aug 2010 (actual)
First posted: 22 Jun 2010 (estimated)
Results: Posted 20 Apr 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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

Effectiveness: No formal effectiveness evaluation will be performed.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Elevess	Experimental	Device: ElevessGel implant (dermal filler) composed of hyaluronan produced by Streptococcus equi (bacterial fermentation) that is cross-linked and suspended in phosphate buffered saline with 0.3% lidocaine HCl and 0.1% sodium metabisulfite

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (12 listed)

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.

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

Primary outcome

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

Results and safety

Results posted to the registry on 20 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Elevess	100	96

Primary outcome: Keloid Formation at Site of Injection

Time frame: 2 Weeks. Number. Unit: percentage of participants

Measure	Elevess n = 97
Value	0.0

Population analysed: Safety Population

Primary outcome: Keloid Formation at Site of Injection

Time frame: 6 Weeks. Number. Unit: Percentage (%) of subjects

Measure	Elevess n = 97
Value	0.0

Population analysed: Safety Population

Primary outcome: Keloid Formation at Site of Injection

Time frame: 12 Weeks. Number. Unit: Percentage (%) of subjects

Measure	Elevess n = 94
Value	0.0

Population analysed: Safety Population

Primary outcome: Keloid Formation at Site of Injection

Time frame: 24 Weeks. Number. Unit: Percentage (%) of subjects

Measure	Elevess n = 98
Value	0.0

Population analysed: Safety Population

Adverse events

Time frame: Adverse Events were recorded to 24 Weeks.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Safety Population	0 of 100 (0%)	47 of 100 (47%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 1974491Kokelj F, Burnett JW. Treatment of a pigmented lesion induced by a Pelagia noctiluca sting. Cutis. 1990 Jul;46(1):62-4.
Background: PubMed 8844357Linder 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.
Background: PubMed 17431730Royston 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.
Background: PubMed 2550287Tomita 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.
Individual participant dataSharing planned: No

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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.

Frederic Brandt, MD principal investigator

Dermatology Research Institute, LLC

William P Coleman, MD principal investigator

Private Practice

Michael Gold, MD principal investigator

Tennessee Clinical Research Center

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Elevess in people with Wrinkles, run by Anika Therapeutics, Inc. at 9 sites 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 3 inclusion and 12 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 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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. 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?

Yes. Results are posted in the registry (first posted 20 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Keloid Formation at Site of Injection (time frame: 2 Weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01147172, which also lists 4 linked publications.

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 17 Oct 2017.