Facial Volume LossNCT02613481
The Emotional and Functional Benefits of Poly-L-Lactic Acid
A study testing Poly-L-Lactic Acid (Sculptra) injection in people with Facial Volume Loss, run by Yardley Dermatology Associates.
Trial summary
This study will evaluates the emotional and functional benefits of Poly-L-Lactic Acid (Sculptra™), a cosmetic product used to fill defects of the skin. All participants will receive Sculptra™. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Volume Loss
- What is being tested?
- Poly-L-Lactic Acid (Sculptra) injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to 1 Aug 2017
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must be an outpatient, male or female subjects of any race, 35 years of age or older.
- Subject must have any degree of facial volume loss.
- Subjects of all Fitzpatrick skin types are eligible.
- Subject must be able to follow study instructions and likely to complete all required visits, as assessed by the Investigator.
- Subject must sign an IRB-approved Informed Consent form, Photographic Release Form, and the Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed.
Who cannot join
- Any of the previous facial treatments:
- Any facial filler in the past 2 years d. Prior injection of permanent facial implant
- Have any skin pathology or condition that could interfere with the evaluation of the face.
- Be unable to communicate or cooperate with the Investigator due to a language barrier (non-English speaking), poor mental development, or impaired cerebral function.
- Have evidence of alcohol or drug abuse (Investigator opinion), or history of poor cooperation, non-compliance with medical treatment, or unreliability.
- Have used an investigational device, biologic or drug in the past 30 days, or be currently participating in an experimental drug, biologic or device trial.
- Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
- Be an employee (or a relative of an employee) of the Investigator, Sponsor or representative of the Sponsor.
About this study
This study will evaluates the emotional and functional benefits of Poly-L-Lactic Acid (Sculptra™), a cosmetic product used to fill defects of the skin. All participants will receive Sculptra™.
Read the detailed description
Facial volume loss can result in emotional distress and functional impairment in some affected individuals. Poly-L-Lactic Acid (Sculptra™) stimulates collagen production in the skin thereby replenishing some of the collagen lost to natural aging and ultraviolet damage. This study will assess the emotional and functional benefits of Poly-L-Lactic Acid treated subject's through self report measurement tools.
- Conditions
- Facial Volume Loss
- Being tested
- Poly-L-Lactic Acid (Sculptra) injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly-L-Lactic Acid (Sculptra) injectionDrug
1 vial of of poly-l-lactic acid (Sculptra) reconstituted in the usual sterile fashion with 7cc of sterile water and 2cc of Lidocaine without epinephrine. The contents of the vial will be injected as deemed appropriate by the certified injector and agreed upon by the study subject.
| Study group | Role | What they receive |
|---|---|---|
| Poly-L-Lactic Acid (Sculptra) injection | Other | Poly-L-Lactic Acid (Sculptra) injection for all enrolled subjects Receives: Drug: Poly-L-Lactic Acid (Sculptra) injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Subject Self Reported Quality of Life Scale
Self report Likert Scale Title: Facial Volume Restoration Outcome Questionnaire 35 Questions 1-7 rating with higher score meaning a worse outcome
Measured: 3 months post initial injection
Mean Rosenberg Self-Esteem Scale
Self reported self esteem measure Title: Rosenberg Self-Esteem Scale Scale of 1-4, scale design with higher score relating to worse outcome.
Measured: 3 months post initial injection
Mean Rosenberg Self-Esteem Scale
Self reported self esteem measure Title: Rosenberg Self-Esteem Scale Scale of 1-4, scale design with higher score relating to worse outcome.
Measured: 6 months post initial injection
Mean Subject Self Reported Quality of Life Scale
Self report Likert Scale Title: Facial Volume Restoration Outcome Questionnaire 35 Questions 1-7 rating with higher score meaning a worse outcome
Measured: 6 months post initial injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion1 Jun 2017
- Study completion1 Aug 2017
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.
- Other trials for Facial Volume LossStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yardley Dermatology Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613481
- Sponsor's protocol ID
- YDA-001
- Status last verified
- May 2019
- First submitted
- 29 Oct 2015
- Last updated
- 29 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Emotional and Functional Benefits of Poly-L-Lactic Acid
- ClinicalTrials.gov ID
- NCT02613481
- Acronym / sponsor ID
- YDA-001
- Conditions
- Facial Volume Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yardley Dermatology AssociatesUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- Nov 2015
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Posted 29 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluates the emotional and functional benefits of Poly-L-Lactic Acid (Sculptra™), a cosmetic product used to fill defects of the skin. All participants will receive Sculptra™.
Detailed description
Facial volume loss can result in emotional distress and functional impairment in some affected individuals. Poly-L-Lactic Acid (Sculptra™) stimulates collagen production in the skin thereby replenishing some of the collagen lost to natural aging and ultraviolet damage. This study will assess the emotional and functional benefits of Poly-L-Lactic Acid treated subject's through self report measurement tools.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Poly-L-Lactic Acid (Sculptra) injection | Other | Drug: Poly-L-Lactic Acid (Sculptra) injectionPoly-L-Lactic Acid (Sculptra) injection for all enrolled subjects |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject must be an outpatient, male or female subjects of any race, 35 years of age or older.
- Subject must have any degree of facial volume loss.
- Subjects of all Fitzpatrick skin types are eligible.
- Subject must be able to follow study instructions and likely to complete all required visits, as assessed by the Investigator.
- Subject must sign an IRB-approved Informed Consent form, Photographic Release Form, and the Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed.
Key exclusion criteria (8 listed)
- Any of the previous facial treatments:
- Have any skin pathology or condition that could interfere with the evaluation of the face.
- Be unable to communicate or cooperate with the Investigator due to a language barrier (non-English speaking), poor mental development, or impaired cerebral function.
- Have evidence of alcohol or drug abuse (Investigator opinion), or history of poor cooperation, non-compliance with medical treatment, or unreliability.
- Have used an investigational device, biologic or drug in the past 30 days, or be currently participating in an experimental drug, biologic or device trial.
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 Acid (Sculptra) injection1 vial of of poly-l-lactic acid (Sculptra) reconstituted in the usual sterile fashion with 7cc of sterile water and 2cc of Lidocaine without epinephrine. The contents of the vial will be injected as deemed appropriate by the certified injector and agreed upon by the study subject. | Drug | Poly-L-Lactic Acid (Sculptra) injection |
Primary outcome
Mean Subject Self Reported Quality of Life Scale
Time frame: 3 months post initial injection
Self report Likert Scale Title: Facial Volume Restoration Outcome Questionnaire 35 Questions 1-7 rating with higher score meaning a worse outcome
Mean Rosenberg Self-Esteem Scale
Time frame: 3 months post initial injection
Self reported self esteem measure Title: Rosenberg Self-Esteem Scale Scale of 1-4, scale design with higher score relating to worse outcome.
Mean Rosenberg Self-Esteem Scale
Time frame: 6 months post initial injection
Self reported self esteem measure Title: Rosenberg Self-Esteem Scale Scale of 1-4, scale design with higher score relating to worse outcome.
Mean Subject Self Reported Quality of Life Scale
Time frame: 6 months post initial injection
Self report Likert Scale Title: Facial Volume Restoration Outcome Questionnaire 35 Questions 1-7 rating with higher score meaning a worse outcome
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for more information about this study: The Emotional and Functional Benefits of Poly-L-Lactic AcidLink 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Poly-L-Lactic Acid (Sculptra) injection in people with Facial Volume Loss, run by Yardley Dermatology Associates.
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 5 inclusion and 8 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 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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 29 May 2019). 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?
Mean Subject Self Reported Quality of Life Scale (time frame: 3 months post initial injection). The study lists 4 primary outcomes in all. 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 29 May 2019.