Skin AgingPhase 4NCT02003833
Poly-L-lactic Acid for Skin Quality
A Phase 4 study testing Poly-L-lactic acid in people with Skin Aging, run by Sadick Research Group at 2 sites in United States.
Trial summary
Anecdotal evidence suggests that patients' skin quality may improve as a result of poly-L-lactic acid injection. While this is not the primary goal of such treatments it is often seen and described as so called "Sculptra glow". Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- Poly-L-lactic acid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2013to Sep 2015
- Phase
- Phase 4
- 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 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained including HIPAA authorization
- Healthy females between 30 and 60 years of age
- Subjects with Fitzpatrick photo skin types I-IV
- Subjects with shallow to deep nasolabial fold contour deficiencies or other facial wrinkles
- Subjects who agree not to have any procedures affecting facial wrinkles (e.g. filler, botulinum toxin, radiofrequency, laser, IPL, ultrasound) for the duration of the study
- Subjects who do agree not to have any other procedures affecting skin quality (microdermabrasion, peels, acne treatments, etc.) for the duration of the study
- Subjects who understand this study and are able to follow study instructions and are willing to attend the required study visits
- Subjects who agree to be photographed for research reasons and their identity may not be concealed in these photographs.
Who cannot join
- Subjects who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy
- Subjects of child-bearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as post-menopausal (absence of menstrual bleeding for one year), hysterectomy or bilateral oophorectomy.
- Subjects who cannot understand or are not willing to comply with the requirements of the study
- Subjects who have a known allergy to poly-L-lactic acid, carboxymethylcellulose, non-pyrogenic mannitol or any anesthetic
- Subjects who have taken any NSAIDs (aspirin, ibuprofen, etc.) within 7 days before treatment
- Subjects who have taken acetaminophen 24 hours before treatment
Show all 20Show fewer
- Subjects who have had fillers or botulinum toxin in the treatment area in the past 12 months
- Subjects who have had treatments with poly-L-lactic acid in the face at any time
- Subjects who have had any kind of facial dermabrasion, chemical peel, laser, or IPL treatment including superficial treatments for aesthetic reasons in the past 6 months or for the duration of the study
- Subjects who does not agree to avoid using tanning beds or intensive exposure to the sun 2 two weeks prior to each office visit.
- Subjects who have any dermatologic conditions including acne, rosacea, eczema, psoriasis, actinic keratosis, severe sun damage, infection or scars within the treatment area
- Subjects who have an active inflammatory process (skin eruptions such as cysts, pimples, rashes or hives) or infection within the treatment area
- Subjects who have any known cancer including skin cancers (basal cell carcinoma, squamous cell carcinoma and melanoma)
- Subjects who have had systemic corticosteroid therapy in the past 6 months or for the duration of the study
- Subjects with a known history of poor wound healing
- Subjects with a known history of keloids (excessive scarring)
- Subjects who are HIV positive
- Subjects who have an existing medical condition that the Investigator considers may put the subject at risk or compromise their participation in the study
- Subjects who have participated in another research study in the past 30 days
- Subjects who are currently involved in any injury litigation claims
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Laser and Skin Surgery Center of Indiana
Carmel, Indiana, 46032
Sadick Research Group
New York, New York, 10075
About this study
Official title: Randomized, Controlled, Multi-Centered, Double-Blind Investigation of Injectable Poly-L-Lactic Acid (Sculptra Aesthetic) for Improving Facial Wrinkles and Skin Quality
Anecdotal evidence suggests that patients' skin quality may improve as a result of poly-L-lactic acid injection. While this is not the primary goal of such treatments it is often seen and described as so called "Sculptra glow".
The aim of this study is to evaluate the effect of repeated subcutaneous injections of poly-L-lactic acid (Sculptra Aesthetic) on skin quality.
Read more
Participating subjects will be part of the study for about 15 months. There will be an initial treatment period of up to 12 weeks, followed by a 12-month follow-up period. There will be a total of 7 scheduled visits.
This study is a double-blind, randomized study. "Double-blind" means that neither the subjects nor the study doctor will know who is receiving Sculptra Aesthetic or placebo. "Randomized" means that the group subjects will be placed in is decided by chance, similar to drawing numbers out of a hat or flipping a coin. Subjects will have a 1 out of 2 chance of receiving the active study drug. After the completion of the study, if subjects are assigned to the control (placebo) group they will receive free injections with Sculptra Aesthetic same as the treatment group.
- Conditions
- Skin Aging
- Being tested
- Poly-L-lactic acid, Placebo comparator
- Keywords
- Poly-L-lactic acid, Sculptra Aesthetic, Skin Quality, Wrinkles, Filler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly-L-lactic acidDevice
Also called Sculptra Aesthetic, P030050/S002
Sculptra injections
Placebo comparatorDevice
Also called Placebo
saline injections
| Study group | Role | What they receive |
|---|---|---|
| Poly-L-lactic acid | Experimental | Subjects in the treatment arm will receive three injections of 5 cc of poly-L-lactic acid (PLLA) into both sides of the face. Receives: Device: Poly-L-lactic acid |
| Placebo | Placebo comparator | Subjects in the placebo arm will receive three injections of 5 cc of saline into both sides of the face. After the completion of the study, subjects in the placebo arm will receive free injections with Sculptra Aesthetic same as the treatment arm. Receives: Device: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in skin quality
The primary endpoint is defined as the degree of improvement in skin quality measured by a blinded, trained evaluator using standardized pictures as well as live evaluations rated by a blinded investigator and the subjects
Measured: 15 months
Secondary outcomes (3)
Improvement of skin physiology
Non-invasive biophysical measurements will be used to assess sub-clinical changes in skin quality including skin hydration, elasticity, density and dermal thickness and a decrease in transepidermal water loss
Measured: 15 months
Investigator and patient satisfaction
Investigator and patient satisfaction will be assessed with a quartile scale.
Measured: 15 months
Safety of repeated injections with Sculptra Aesthetic
Safety analyses will be done on all treated patients, defined by any subject who received at least one study treatment. Compiled side effects, including all expected or unexpected side effects but not limited to site discomfort, redness, bruising, bleeding, itching, and swelling, small and larger lumps under the skin
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sadick Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neil Sadick, Sadick Research Group
- Investigators
- Neil S Sadick, MD, Principal investigator, Sadick Research GroupWilliam Hanke, MD, Principal investigator, Laser and Skin Surgery Center of Indiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003833
- Sponsor's protocol ID
- PLLA SkinQ
- Status last verified
- Nov 2015
- First submitted
- 2 Dec 2013
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Multi-Centered, Double-Blind Investigation of Injectable Poly-L-Lactic Acid (Sculptra Aesthetic) for Improving Facial Wrinkles and Skin Quality
- ClinicalTrials.gov ID
- NCT02003833
- Acronym / sponsor ID
- PLLA SkinQ
- Conditions
- Skin Aging
- Keywords
- Poly-L-lactic acid, Sculptra Aesthetic, Skin Quality, Wrinkles, Filler
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sadick Research GroupUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 6 Dec 2013 (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.
Anecdotal evidence suggests that patients' skin quality may improve as a result of poly-L-lactic acid injection. While this is not the primary goal of such treatments it is often seen and described as so called "Sculptra glow".
The aim of this study is to evaluate the effect of repeated subcutaneous injections of poly-L-lactic acid (Sculptra Aesthetic) on skin quality.
Participating subjects will be part of the study for about 15 months. There will be an initial treatment period of up to 12 weeks, followed by a 12-month follow-up period. There will be a total of 7 scheduled visits.
This study is a double-blind, randomized study. "Double-blind" means that neither the subjects nor the study doctor will know who is receiving Sculptra Aesthetic or placebo. "Randomized" means that the group subjects will be placed in is decided by chance, similar to drawing numbers out of a hat or flipping a coin. Subjects will have a 1 out of 2 chance of receiving the active study drug. After the completion of the study, if subjects are assigned to the control (placebo) group they will receive free injections with Sculptra Aesthetic same as the treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Poly-L-lactic acid | Experimental | Device: Poly-L-lactic acidSubjects in the treatment arm will receive three injections of 5 cc of poly-L-lactic acid (PLLA) into both sides of the face. |
| Placebo | Placebo comparator | Device: Placebo comparatorSubjects in the placebo arm will receive three injections of 5 cc of saline into both sides of the face. After the completion of the study, subjects in the placebo arm will receive free injections with Sculptra Aesthetic same as the treatment arm. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained including HIPAA authorization
- Healthy females between 30 and 60 years of age
- Subjects with Fitzpatrick photo skin types I-IV
- Subjects with shallow to deep nasolabial fold contour deficiencies or other facial wrinkles
- Subjects who agree not to have any procedures affecting facial wrinkles (e.g. filler, botulinum toxin, radiofrequency, laser, IPL, ultrasound) for the duration of the study
Key exclusion criteria (20 listed)
- Subjects who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy
- Subjects of child-bearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as post-menopausal (absence of menstrual bleeding for one year), hysterectomy or bilateral oophorectomy.
- Subjects who cannot understand or are not willing to comply with the requirements of the study
- Subjects who have a known allergy to poly-L-lactic acid, carboxymethylcellulose, non-pyrogenic mannitol or any anesthetic
- Subjects who have taken any NSAIDs (aspirin, ibuprofen, etc.) within 7 days before treatment
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 |
|---|---|---|
| Poly-L-lactic acidAlso: Sculptra Aesthetic, P030050/S002Sculptra injections | Device | Poly-L-lactic acid |
| Placebo comparatorAlso: Placebosaline injections | Device | Placebo |
Primary outcome
Improvement in skin quality
Time frame: 15 months
The primary endpoint is defined as the degree of improvement in skin quality measured by a blinded, trained evaluator using standardized pictures as well as live evaluations rated by a blinded investigator and the subjects
3 secondary outcomes
Improvement of skin physiology
Time frame: 15 months
Investigator and patient satisfaction
Time frame: 15 months
Safety of repeated injections with Sculptra Aesthetic
Time frame: 15 months
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 20 Nov 2015.
- Laser and Skin Surgery Center of IndianaLink provided by the sponsor.
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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.
Neil S Sadick, MD principal investigator
Sadick Research Group
William Hanke, MD principal investigator
Laser and Skin Surgery Center of Indiana
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Poly-L-lactic acid in people with Skin Aging, run by Sadick Research Group at 2 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 8 inclusion and 20 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 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improvement in skin quality (time frame: 15 months). 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 20 Nov 2015.