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Biostimulator
Biostimulator + Skincare Regimen for Midface Volume Deficiency
N/A
Waitlist Available
Led By Orit Markowitz, MD
Research Sponsored by Galderma R&D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, at 6 weeks, 12 weeks, and 18 weeks after baseline
Awards & highlights
Study Summary
This trial tested a treatment to improve skin structure in the midface that used light waves to stimulate skin cells.
Who is the study for?
This trial is for individuals with moderate-to-severe cheek wrinkles and mild-to-severe photodamage on both sides of the midface. Participants must need two biostimulator treatments, be able to consent, follow study procedures, and attend scheduled assessments. Those with allergies to treatment ingredients or uneven facial features, recent facial treatments, or conditions affecting study participation are excluded.Check my eligibility
What is being tested?
The study tests how well a biostimulator (Sculptra) paired with different skincare regimens (Alastin Restorative Skin Complex or CeraVe Daily Moisturizing Lotion) improves midface skin structure. The effects will be measured using Line-Field Optical Coherence Tomography after the treatments.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site such as redness, swelling, pain or bruising; allergic responses to product ingredients; and other skin-related issues that can vary from person to person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, at 6 weeks, 12 weeks, and 18 weeks after baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, at 6 weeks, 12 weeks, and 18 weeks after baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Structural change in midface post-treatment with a biostimulator compared to pre-treatment
Secondary outcome measures
Improvement in clinical grading score compared to pre-treatment
Subject satisfaction using a self-assessment questionnaire
Trial Design
2Treatment groups
Active Control
Group I: Biostimulator and Facial Moisturizer AActive Control1 Intervention
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.
Group II: Biostimulator and Facial Moisturizer BActive Control1 Intervention
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.
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Who is running the clinical trial?
Galderma R&DLead Sponsor
299 Previous Clinical Trials
60,399 Total Patients Enrolled
Orit Markowitz, MDPrincipal InvestigatorMarkowitz Medical
2 Previous Clinical Trials
25 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor thinks I need 2 biostimulator treatments for the best outcome.I haven't had any facial treatments in the last 6 months that would affect this study.I have moderate-to-severe cheek wrinkles on both sides of my face.I have noticeable sun damage on both sides of my face.I have had facial treatments, but not on my lips.
Research Study Groups:
This trial has the following groups:- Group 1: Biostimulator and Facial Moisturizer A
- Group 2: Biostimulator and Facial Moisturizer B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible to sign up for this experiment at the moment?
"A review of clinicaltrials.gov discloses that this research trial is actively enrolling patients. It initially went live on July 7th 2023, and the last edit was made on July 18th 2023."
Answered by AI
How many participants are currently taking part in the experiment?
"Affirmative. Clinical trials website data affirms that this clinical study, first posted on July 7th 2023, is actively recruiting participants. Approximately 20 patients are being sought from 1 specific medical facility."
Answered by AI
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