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NCT04957446
Histology Study of Biostimulatory Activity of Injectable Poly-L-Lactic Acid (Sculptra Aesthetic)
NA trial testing Sculptra Aesthetic in Nasolabial Fold in 10 participants. Status unknown.
1 July 2022
Quick facts
| Lead sponsor | Sadick Research Group |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 9 August 2021 |
| Primary completion | 1 July 2022 |
| Estimated completion | 1 September 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Sculptra Aesthetic — full drug profile →
- Placebo
Conditions studied
- Nasolabial Fold — all drugs for Nasolabial Fold →
- Facial Wrinkles — all drugs for Facial Wrinkles →
Sponsor
Sadick Research Group
Who can join
Adults 30 to 65, any sex, with Nasolabial Fold or Facial Wrinkles. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04957446
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Related trials
Other trials of Sculptra Aesthetic
Trials testing the same drug.
- NCT07202117 — PLLA and CaHA-R for Aesthetic Rejuvenation · Phase 4 · recruiting
- NCT07217743 — Assess Impact of Poly-L-lactic Acid on GLP1 Subjects · Phase 2 · not yet recruiting
- NCT07205744 — Post-Menopause Skin Rejuvenation Study · Phase 4 · active not recruiting
- NCT05463978 — Sculptra Chart Review · completed
- NCT04830722 — Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Cellulite of the Buttocks and Thighs · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04957446 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sadick Research Group
- Last refreshed: 11 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04957446.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing