Face; AtrophyNCT02310490
DA-13-007 Versus Sculptra for the Treatment of Nasolabial Folds Wrinkles
A study testing DA-13-007 right with left side Sculptra left side and DA-13-007 left with left side Sculptra right side in people with Face; Atrophy, run by DermAvance at 4 sites in United States.
Trial summary
Study DA-13-007 is a randomized, evaluator-blinded, within subject (split face) multicenter clinical study of DA-13-007l (Injectable poly-l-lactic acid) compared to SCULPTRA in the treatment of nasolabial fold wrinkles. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Face; Atrophy
- What is being tested?
- DA-13-007 right with left side Sculptra left side and DA-13-007 left with left side Sculptra right side
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Outpatient, male or female subjects of any race 21 years or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at the Baseline Visit (test must have a sensitivity of at least 50U/mL for human chorionic gonadotropin) and practice a reliable method of contraception throughout the study.
- A female is considered of childbearing potential unless she is
- postmenopausal for at least 12 months prior to study drug administration;
- without a uterus and/or both ovaries; or
- has been surgically sterile for at least 6 months prior to study drug administration.
- Reliable methods of contraception are:
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- hormonal methods or intrauterine device in use >30 days prior to study drug administration; or
- barrier methods plus spermicide in use at least 14 days prior to study drug administration
- vasectomized partner at least 3 months post operative or a zero sperm count post operatively 2. Demonstrate clinical evidence of moderate to severe bilateral aging in the nasolabial area, with wrinkles classified as a grade 3 or grade 4 on a 5-grade WSRS.
- 3. Committed to abstain from procedures interfering with the treatment outcome (exclusion criteria) throughout the study.
- 4. Able to understand the requirements of the study and sign Informed Consent and Photography Release forms.
Who cannot join
- Pregnant (positive urine pregnancy test), are planning to become pregnant during the study period, have an infant they are breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
- Subjects planning a facial cosmetic procedure during the study period or with prior cosmetic procedures (i.e., surgery) or visible scars that may affect the evaluation of response and/or quality of photography.
- Facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or an inability to substantially lessen upper facial rhytids even by physically spreading them apart.
- Active skin disease within the treatment area within 6 months prior to study entry.
- History of malignancy, excluding non-melanoma skin cancer within the past 5 years.
- Profound atrophy/excessive weakness of muscles in target areas of injection.
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- History of facial nerve palsy.
- Facial wrinkles therapy, such a permanent or enduring dermal fillers in the previous 2 years or bioresorbable during the previous 12 months.
- Allergy or sensitivity to any component of the study medication (Section 8.1), or a known sensitivity to local anesthetics.
- Previous botulinum toxin therapy within six (6) months of the Baseline Visit.
- Use of systemic prednisone, penicillamine, anti metabolites or other bioequivalent collagen production inhibitors within 3 months of the Baseline Visit.
- Has received (or is planning to receive) anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti-inflammatory drugs (oral/injectable corticosteroids or non-steroidal anti inflammatory, eg.,aspirin, ibuprofen), or other substances known to increase coagulation time (e.g., Vitamin E, garlic, gingko). To clarify, no non-steroidal anti inflammatory e.g. asprin or ibuprofen within 10 days prior to injections or 3 days post injection.
- Evidence of recent alcohol or drug abuse.
- Medical and/or psychiatric problems that, in the Investigator's opinion, is severe enough to interfere with the study results.
- History of poor cooperation, non-compliance with medical treatment, or unreliability.
- Participation in an investigational drug or investigational device study within 3 months of the Baseline Visit.
- A history of connective tissue disease (rheumatoid Arthritis, arthritis, lupus).
- A history of multiple severe allergies or a history of anaphylactic shock.
- Patients with a known history of or susceptibility to keloid formation or hypertrophic scarring.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Bay Area Dermatology
Bradenton, Florida, 34209
Laser & Skin Surgery Center of Indiana
Carmel, Indiana, 46032
Miami Skin Institute
Coral Gables, Florida, 33146
PCR
Spokane, Washington, 99202
About this study
Official title: A Controlled, Randomized, Within-subject, Multi-center Prospective Clinical Trial of DA-13-007 (Injectable Poly-L-lactic Acid) Versus SCULPTRA® Aesthetic (Injectable Poly-L-lactic Acid) in the Treatment of Nasolabial Fold Wrinkles.
Study DA-13-007 is a randomized, evaluator-blinded, within subject (split face) multicenter clinical study of DA-13-007l (Injectable poly-l-lactic acid) compared to SCULPTRA in the treatment of nasolabial fold wrinkles. Qualifying subjects will be randomized to receive DA-13-007l and SCULPTRA on either the right or left side of the face.
Read the detailed description
A randomized, evaluator-blinded, within subject (split face) multicenter clinical study of DA-13-007 (Injectable poly-l-lactic acid) compared to SCULPTRA in the treatment of nasolabial fold wrinkles. Qualifying subjects will be randomized to receive DA-13-007 and SCULPTRA on either the right or left side of the face. The treatment phase will consist of one to three visits at 3 week intervals during which eligible subjects will receive bilateral injections of study material in the left and right nasolabial fold wrinkles, including visits at weeks 3 and 6 for touch ups if needed. The follow-up phase will consist of assessments at 1, 3, 6, and 12 months after the last treatment, and safety and efficacy evaluations for an additional 12 months. Standardized photographs will be taken at screening and at all treatment phase and follow-up visits. Efficacy evaluations will be made by an on-site blinded evaluator, and of the photographs using a validated, standardized photo-numeric scale. The primary efficacy comparison between study treatments will be made on the mean change from baseline in the Wrinkle Severity Rating Scale of the nasolabial folds (as determined by the on-site blinded evaluator) and at the 12 month time point. Study participants will continue to be followed for safety and efficacy at months 18 and 24 after their last injection session.
- Conditions
- Face; Atrophy
- Being tested
- DA-13-007 right with left side Sculptra left side, DA-13-007 left with left side Sculptra right side
- Keywords
- Nasolabial Folds
- Medical subject headings
- Facies, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-13-007 right with left side Sculptra left sideDevice
The treatment phase will consist of one to three visits at 3 week intervals during which eligible subjects will receive bilateral injections of study material in the left and right nasolabial fold wrinkles, including visits at weeks 3 and 6 for touch ups if needed
DA-13-007 left with left side Sculptra right sideDevice
The treatment phase will consist of one to three visits at 3 week intervals during which eligible subjects will receive bilateral injections of study material in the left and right nasolabial fold wrinkles, including visits at weeks 3 and 6 for touch ups if needed
| Study group | Role | What they receive |
|---|---|---|
| Right Side DA-13-007, Left Side Sculptra | Active comparator | DA-13-007 right with left side Sculptra left side Receives: Device: DA-13-007 right with left side Sculptra left side |
| Left Side DA-13-007, Right Side Sculptra | Active comparator | DA-13-007 left with Sculptra right side Receives: Device: DA-13-007 left with left side Sculptra right side |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of treatment vs Comparator (using a 5-grade WSRS (wrinkle severity rating scale) score and a rating by an independent evaluator)
To evaluate the efficacy of treatment versus the comparator in a non-inferiority statistical model using a 5-grade WSRS (wrinkle severity rating scale) score and a rating by an independent evaluator
Measured: One Year
Secondary outcomes (2)
To evaluate the Global aesthetic improvement as assessed by investigators and subjects
- To evaluate the Global aesthetic improvement (GAI) as assessed by investigators and subjects
Measured: Two Year
To evaluate subjects satisfaction using a six point subject satisfaction questionnaire.
To evaluate subjects satisfaction using a six point subject satisfaction questionnaire.
Measured: Two Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Face; AtrophyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- DermAvance
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Werschler, MD, Principal investigator, Premier Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310490
- Sponsor's protocol ID
- DermAvance DA-13-007
- Status last verified
- Jul 2024
- First submitted
- 3 Dec 2014
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Randomized, Within-subject, Multi-center Prospective Clinical Trial of DA-13-007 (Injectable Poly-L-lactic Acid) Versus SCULPTRA® Aesthetic (Injectable Poly-L-lactic Acid) in the Treatment of Nasolabial Fold Wrinkles.
- ClinicalTrials.gov ID
- NCT02310490
- Acronym / sponsor ID
- DermAvance DA-13-007
- Conditions
- Face; Atrophy
- Keywords
- Nasolabial Folds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- DermAvanceIndustry (pharma, biotech, devices)
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study DA-13-007 is a randomized, evaluator-blinded, within subject (split face) multicenter clinical study of DA-13-007l (Injectable poly-l-lactic acid) compared to SCULPTRA in the treatment of nasolabial fold wrinkles. Qualifying subjects will be randomized to receive DA-13-007l and SCULPTRA on either the right or left side of the face.
Detailed description
A randomized, evaluator-blinded, within subject (split face) multicenter clinical study of DA-13-007 (Injectable poly-l-lactic acid) compared to SCULPTRA in the treatment of nasolabial fold wrinkles. Qualifying subjects will be randomized to receive DA-13-007 and SCULPTRA on either the right or left side of the face. The treatment phase will consist of one to three visits at 3 week intervals during which eligible subjects will receive bilateral injections of study material in the left and right nasolabial fold wrinkles, including visits at weeks 3 and 6 for touch ups if needed. The follow-up phase will consist of assessments at 1, 3, 6, and 12 months after the last treatment, and safety and efficacy evaluations for an additional 12 months. Standardized photographs will be taken at screening and at all treatment phase and follow-up visits. Efficacy evaluations will be made by an on-site blinded evaluator, and of the photographs using a validated, standardized photo-numeric scale. The primary efficacy comparison between study treatments will be made on the mean change from baseline in the Wrinkle Severity Rating Scale of the nasolabial folds (as determined by the on-site blinded evaluator) and at the 12 month time point. Study participants will continue to be followed for safety and efficacy at months 18 and 24 after their last injection session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right Side DA-13-007, Left Side Sculptra | Active comparator | Device: DA-13-007 right with left side Sculptra left sideDA-13-007 right with left side Sculptra left side |
| Left Side DA-13-007, Right Side Sculptra | Active comparator | Device: DA-13-007 left with left side Sculptra right sideDA-13-007 left with Sculptra right side |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Outpatient, male or female subjects of any race 21 years or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at the Baseline Visit (test must have a sensitivity of at least 50U/mL for human chorionic gonadotropin) and practice a reliable method of contraception throughout the study.
- 3. Committed to abstain from procedures interfering with the treatment outcome (exclusion criteria) throughout the study.
- 4. Able to understand the requirements of the study and sign Informed Consent and Photography Release forms.
Key exclusion criteria (19 listed)
- Pregnant (positive urine pregnancy test), are planning to become pregnant during the study period, have an infant they are breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
- Subjects planning a facial cosmetic procedure during the study period or with prior cosmetic procedures (i.e., surgery) or visible scars that may affect the evaluation of response and/or quality of photography.
- Facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or an inability to substantially lessen upper facial rhytids even by physically spreading them apart.
- Active skin disease within the treatment area within 6 months prior to study entry.
- History of malignancy, excluding non-melanoma skin cancer within the past 5 years.
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 |
|---|---|---|
| DA-13-007 right with left side Sculptra left sideThe treatment phase will consist of one to three visits at 3 week intervals during which eligible subjects will receive bilateral injections of study material in the left and right nasolabial fold wrinkles, including visits at weeks 3 and 6 for touch ups if needed | Device | Right Side DA-13-007, Left Side Sculptra |
| DA-13-007 left with left side Sculptra right sideThe treatment phase will consist of one to three visits at 3 week intervals during which eligible subjects will receive bilateral injections of study material in the left and right nasolabial fold wrinkles, including visits at weeks 3 and 6 for touch ups if needed | Device | Left Side DA-13-007, Right Side Sculptra |
Primary outcome
Efficacy of treatment vs Comparator (using a 5-grade WSRS (wrinkle severity rating scale) score and a rating by an independent evaluator)
Time frame: One Year
To evaluate the efficacy of treatment versus the comparator in a non-inferiority statistical model using a 5-grade WSRS (wrinkle severity rating scale) score and a rating by an independent evaluator
2 secondary outcomes
To evaluate the Global aesthetic improvement as assessed by investigators and subjects
Time frame: Two Year
To evaluate subjects satisfaction using a six point subject satisfaction questionnaire.
Time frame: Two Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
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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.
William Werschler, MD principal investigator
Premier Clinical Research
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DA-13-007 right with left side Sculptra left side and DA-13-007 left with left side Sculptra right side in people with Face; Atrophy, run by DermAvance at 4 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 11 inclusion and 19 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 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy of treatment vs Comparator (using a 5-grade WSRS (wrinkle severity rating scale) score and a rating by an independent evaluator) (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2024.