Photodamaged SkinNCT05963204
A Study to Evaluate the Effects for Midface Improvement When Pairing a Biostimulator with a Skincare Regimen
A study testing Sculptra and Alastin Restorative Skin Complex and Sculptra and CeraVe Daily Moisturizing Lotion in people with Photodamaged Skin and Volume Deficiency of the Midface, run by Galderma R&D at 1 site in United States.
Trial summary
To assess skin structural change in midface after treatment with a biostimulator using Line-Field Optical Coherence Tomography Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Photodamaged Skin, Volume Deficiency of the Midface
- What is being tested?
- Sculptra and Alastin Restorative Skin Complex and Sculptra and CeraVe Daily Moisturizing Lotion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2023to 19 Mar 2024
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects diagnosed with symmetrical, moderate-to-severe cheek wrinkles on each side of the face as assessed via the Galderma Cheek Wrinkles Scale.
- Subjects with symmetrical, mild-to-severe photodamage at both sides of the midface.
- Subject who in the opinion of the treating investigator would need 2 biostimulator treatments for optimal clinical outcomes.
- Ability of giving consent for participation in the study.
- Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments.
Who cannot join
- Subjects with asymmetrical severity or unidentical cheek wrinkle score between 2 sides of the cheek.
- Asymmetrical severity photodamage score between 2 sides of the midface.
- Subjects with a history of allergy or hypersensitivity to any ingredient of the treatment products.
- Previous tissue-augmenting therapy, contouring, or revitalization treatment in the face, except lips.
- Previous treatment/procedure in the face in the previous 6 months that, in the Investigator's opinion, would interfere with the study injections and/or study assessments or exposed the study subject to undue risk by study participation, or planning to undergo any of these procedures affecting the treatment area at any time during the study.
- Subjects with any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blinded, Split-face, Comparative Study to Evaluate the Synergistic Effects for Improving the Aging Midface When Pairing a Biostimulator with a Skincare Regimen
To assess skin structural change in midface after treatment with a biostimulator using Line-Field Optical Coherence Tomography
Read the detailed description
This is a randomized, double-blinded, split-face, comparative study.
This study is designed to enroll and randomize approximately 20 subjects. All subjects are to have midface volume loss and contour deficiency and facial photodamage.
Eligible subjects are randomized to receive study skincare products for pre-conditioning, 2 weeks before Baseline. All subjects receive biostimulator treatment at the midface by the Treating Investigator at Baseline. The method of injection is at the discretion of the Treating Investigator. A sufficient amount of product is injected to achieve optimal correction of the midface, in the opinion of the Treating Investigator.
At the 6-week visit, after all study procedures for the visit are completed, treated subjects received a second biostimulator treatment to achieve optimal aesthetic improvement. At the 12-week and 18-week visits, similar study procedures are performed.
- Being tested
- Sculptra and Alastin Restorative Skin Complex, Sculptra and CeraVe Daily Moisturizing Lotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sculptra and Alastin Restorative Skin ComplexCombination product
Biostimulator and cosmetics
Sculptra and CeraVe Daily Moisturizing LotionCombination product
Biostimulator and cosmetics
| Study group | Role | What they receive |
|---|---|---|
| Biostimulator and Facial Moisturizer A | Active comparator | Biostimulator is sterile dry powder poly L-lactic acid with sodium carboxymethylcellulose, non-pyrogenic mannitol. Mode of administration: injection. Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and at week 6.
Facial Moisturizer A is a cream with active TriHex technology. Mode of administration: topical application. Frequency and duration: twice daily on half of the face for the entire study. Receives: Combination Product: Sculptra and Alastin Restorative Skin Complex |
| Biostimulator and Facial Moisturizer B | Active comparator | Biostimulator is sterile dry powder poly L-lactic acid with sodium carboxymethylcellulose, non-pyrogenic mannitol. Mode of administration: injection. Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and at week 6.
Facial Moisturizer B is a neutral, oil-free moisturizing lotion. Mode of administration: topical application. Frequency and duration: twice daily on half of the face for the entire study. Receives: Combination Product: Sculptra and CeraVe Daily Moisturizing Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural change in midface post-treatment with a biostimulator compared to pre-treatment
Percent change in collagen fiber density using Line-Field Confocal Optical Coherence Tomography at defined timepoints compared to baseline. Collagen density is defined as a number of fibers and is measured on each side of the midface.
Measured: 6 weeks and 18 weeks after Baseline
Secondary outcomes (2)
Improvement in clinical grading score compared to pre-treatment
Percent change in skin parameters includes photodamage, roughness, radiance at defined timepoints compared to re-treatment. Each parameter is assessed by the Investigator on each side of the face using a 10-point Modified Griffiths' scale where 0 = none and 9 = severe.
Measured: Baseline, at 6 weeks, 12 weeks, and 18 weeks after Baseline
Subject satisfaction using a self-assessment questionnaire
Survey where subjects are asked about their satisfaction with treatment outcome on each half of their face. A 5-point subject satisfaction questionnaire with the following responses: strongly agree, agree, neither agree nor disagree, disagree, strongly disagree.
Measured: Baseline, at 6 weeks, 12 weeks, and 18 weeks after Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start7 Jul 2023
- Primary completion19 Mar 2024
- Study completion19 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photodamaged SkinStudies 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, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Orit Markowitz, MD, Principal investigator, Markowitz Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963204
- Sponsor's protocol ID
- GLI.04.US.SL.023
- Status last verified
- Oct 2024
- First submitted
- 29 Jun 2023
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Split-face, Comparative Study to Evaluate the Synergistic Effects for Improving the Aging Midface When Pairing a Biostimulator with a Skincare Regimen
- ClinicalTrials.gov ID
- NCT05963204
- Acronym / sponsor ID
- GLI.04.US.SL.023
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 27 Jul 2023 (actual)
- 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.
To assess skin structural change in midface after treatment with a biostimulator using Line-Field Optical Coherence Tomography
Detailed description
This is a randomized, double-blinded, split-face, comparative study.
This study is designed to enroll and randomize approximately 20 subjects. All subjects are to have midface volume loss and contour deficiency and facial photodamage.
Eligible subjects are randomized to receive study skincare products for pre-conditioning, 2 weeks before Baseline. All subjects receive biostimulator treatment at the midface by the Treating Investigator at Baseline. The method of injection is at the discretion of the Treating Investigator. A sufficient amount of product is injected to achieve optimal correction of the midface, in the opinion of the Treating Investigator.
At the 6-week visit, after all study procedures for the visit are completed, treated subjects received a second biostimulator treatment to achieve optimal aesthetic improvement. At the 12-week and 18-week visits, similar study procedures are performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biostimulator and Facial Moisturizer A | Active comparator | Combination Product: Sculptra and Alastin Restorative Skin ComplexBiostimulator is sterile dry powder poly L-lactic acid with sodium carboxymethylcellulose, non-pyrogenic mannitol. Mode of administration: injection. Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and at week 6. Facial Moisturizer A is a cream with active TriHex technology. Mode of administration: topical application. Frequency and duration: twice daily on half of the face for the entire study. |
| Biostimulator and Facial Moisturizer B | Active comparator | Combination Product: Sculptra and CeraVe Daily Moisturizing LotionBiostimulator is sterile dry powder poly L-lactic acid with sodium carboxymethylcellulose, non-pyrogenic mannitol. Mode of administration: injection. Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and at week 6. Facial Moisturizer B is a neutral, oil-free moisturizing lotion. Mode of administration: topical application. Frequency and duration: twice daily on half of the face for the entire study. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects diagnosed with symmetrical, moderate-to-severe cheek wrinkles on each side of the face as assessed via the Galderma Cheek Wrinkles Scale.
- Subjects with symmetrical, mild-to-severe photodamage at both sides of the midface.
- Subject who in the opinion of the treating investigator would need 2 biostimulator treatments for optimal clinical outcomes.
- Ability of giving consent for participation in the study.
- Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments.
Key exclusion criteria (6 listed)
- Subjects with asymmetrical severity or unidentical cheek wrinkle score between 2 sides of the cheek.
- Asymmetrical severity photodamage score between 2 sides of the midface.
- Subjects with a history of allergy or hypersensitivity to any ingredient of the treatment products.
- Previous tissue-augmenting therapy, contouring, or revitalization treatment in the face, except lips.
- Previous treatment/procedure in the face in the previous 6 months that, in the Investigator's opinion, would interfere with the study injections and/or study assessments or exposed the study subject to undue risk by study participation, or planning to undergo any of these procedures affecting the treatment area at any time during 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 |
|---|---|---|
| Sculptra and Alastin Restorative Skin ComplexBiostimulator and cosmetics | Combination product | Biostimulator and Facial Moisturizer A |
| Sculptra and CeraVe Daily Moisturizing LotionBiostimulator and cosmetics | Combination product | Biostimulator and Facial Moisturizer B |
Primary outcome
Structural change in midface post-treatment with a biostimulator compared to pre-treatment
Time frame: 6 weeks and 18 weeks after Baseline
Percent change in collagen fiber density using Line-Field Confocal Optical Coherence Tomography at defined timepoints compared to baseline. Collagen density is defined as a number of fibers and is measured on each side of the midface.
2 secondary outcomes
Improvement in clinical grading score compared to pre-treatment
Time frame: Baseline, at 6 weeks, 12 weeks, and 18 weeks after Baseline
Subject satisfaction using a self-assessment questionnaire
Time frame: Baseline, at 6 weeks, 12 weeks, and 18 weeks after Baseline
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 24 Oct 2024.
- 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.
Orit Markowitz, MD principal investigator
Markowitz Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sculptra and Alastin Restorative Skin Complex and Sculptra and CeraVe Daily Moisturizing Lotion in people with Photodamaged Skin and Volume Deficiency of the Midface, run by Galderma R&D at 1 site 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 5 inclusion and 6 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 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Structural change in midface post-treatment with a biostimulator compared to pre-treatment (time frame: 6 weeks and 18 weeks after Baseline). 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 24 Oct 2024.