An interventional study of Sculptra aesthetic in Lipoatrophy and Aging, sponsored by Sadick Research Group. Status unknown. Open to participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by Sadick Research Group · Not applicable, Interventional, and Treatment
Temporal volume loss is part of the natural aging process of the face. It is primarily the consequence of fat pad atrophy, but bone loss, ligament weakening, soft tissue, and muscle also contribute. . The goal of the study is to evaluate the volumizing and bio-stimulatory effects of sculptra injections in the temples.
This is a prospective, single-site, open label study to assess the safety and efficacy of injectable Poly-L-Lactic Acid (Sculptra aesthetic) for volume loss in the temples using dual plane injections. Eligible subjects will get up to 3 treatments four weeks apart with poly-L-lactic acid, (Sculptra) in the temples. After the treatments, subjects will return to the research site 1 month and 6 months post last treatment for follow up visits.Eligible subjects will get up to 3 treatment sessions 4 weeks apart with ether Sculptra® Aesthetic or saline following a randomized list. During the study period, subjects will return to the research site for visits at 5 and 6 months post baseline (±7 days).
139 studies on the registry are indexed under Lipodystrophy; 10 are open to participants now.
This study's planned enrollment of 20 is below the median of 46 across 97 interventional studies indexed under Lipodystrophy.
Browse Lipodystrophy studies →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.
Device: Sculptra aesthetic
The goal of the study is to evaluate the volumizing and bio-stimulatory effects of sculptra injections in the temples with total volume of the diluted product as 9 ml (8 ml of sterile water and 1 ml of Lidocaine).
Clinical evaluation of PLLA injection for efficacy, to restore the volume loss in temporal area
at least one degree of improvement in the temporal area volume using the Galderma Temple Volume Deficit Scale (Moradi et al Dermatol Surg. 2020 Sep;46(9): 1148-1154) and GAIS at the last follow up as compared to baseline.
Time frame: 16 weeks
Improvement of facial skin laxity
Improvement of facial skin laxity will be defined as at least 1 point of improvement in the facial area using the 10-point facial laxity rating scale (Silva Hector, Dermatol Surg.2016 Dec;42(12):1370-1379) from baseline throughout week 36.
Time frame: 16 weeks
Adverse events
Safety will be assessed throughout the study by monitoring adverse events clinically and by Ultrasound imaging.
Time frame: 16 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Sadick Research Group