An interventional study of Sculptra Aesthetic and Placebo in Nasolabial Fold and Facial Wrinkles, sponsored by Sadick Research Group. Status unknown at 1 site in United States. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-08-11.
Sponsored by Sadick Research Group · Not applicable, Interventional, and Treatment
The study device, Sculptra, is an injectable implant formulation of poly-L-lactic acid microbeads, approved by the FDA for treatment of facial fat loss (lipoatrophy of HIV disease). It is being used off-label by dermatologists to treat dermal defects, as a biologically active filler. Anecdotal evidence suggests that subjects' 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". Based upon the study doctor's experience global skin quality improvement includes radiance, smoothness and pigment uniformity as well as a decrease in skin redness and pore size. In this study we evaluate the existence of histopathological (microscopic examination of tissue) evidence that can explain the observed improvement of skin quality after poly-L-lactic acid injections. Specifically, we will use histopathologic techniques to investigate effects of Sculptra injections into human skin with regard to restoring skin health and epidermal thickness.
Sculptra is a formulation of poly-L-lactic acid microbeads, approved by the FDA for treatment of facial fat loss (lipoatrophy of HIV disease). It is being used off-label by dermatologists to treat dermal defects, as a biologically active filler. 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".
Based upon the investigator's experience global skin quality improvement includes radiance, smoothness and pigment uniformity as well as a decrease of erythema index and pore size. In this study we evaluate the existence of histopathological evidence that can elucidate the observed improvement of skin quality after poly-L-lactic acid injections. Specifically we will use histopathologic techniques to investigate effects of Sculptra injections into human skin with regard to dermal remodeling and epidermal thickness.This is a randomized, controlled, double-blind single-center study. The treatment phase will consist of a baseline visit, visits at 4-week and 8-weeks during which eligible subjects will receive injections of 5 cc of poly-L-lactic acid (PLLA) for the treatment group or saline for the control group into both sides of the face.
Seven eligible subjects will receive injections of 5 cc of poly-L-lactic acid (PLLA) for the study treatment group and 3 subjects will receive saline for the control group into both sides of the face.
The biopsy portion of the study, a punch biopsy will be collected at 4 timepoints throughout the study: at baseline prior to study treatment one, 4 weeks post study treatment one, 48 hours post study treatment three, and 18 weeks post study treatment.
Participation is up to 28 weeks and will attend approximately 6 study visits. The subject participation period includes a screening period of up to 2 weeks, three injections at 4-week intervals, and a follow-up visit at 48 hours and 18 weeks after the last injection.
to evaluate the histological effect and the "duration" of repeated subcutaneous injections of poly-L-lactic acid (PLLA) on skin quality. As skin SRG-PLLA-02 quality improvement the histopathological analysis with assess expression of procollagen 1, CD31 (vessels), SMA (myofibroblasts), CD163 (macrophages), CD117 (mast cells), \& Elastin.
Sadick Research Group is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive 3 treatments of 1mL Poly-L-Lactic Acid (Sculptra Aesthetic)
Device: Sculptra Aesthetic
Subjects will receive 3 treatments of 1mL Saline solution.
Other: Placebo
Injectable implant containing microparticles of poly-L-lactic acid (PLLA)
Saline solution
Histological effect
The primary outcome measure is defined as the degree of improvement in skin quality based on the expression of tissue markers measured by a blinded histopathologist.
Time frame: 12 weeks
Skin Improvement
The secondary outcome measure 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.
Time frame: 18 weeks
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Sadick Research Group