NCT04830722 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Davis DS, Boen M, Fabi SG
Cellulite: Patient Selection and Combination Treatments for Optimal Results-A Review and Our Experience. Dermatol Surg. 2019 Sep;45(9):1171-1184. doi: 10.1097/DSS.0000000000001776. Review.
Haddad A, Menezes A, Guarnieri C, Coimbra D, Ribeiro E, Sarubi J, Avelar LE, Del Nero MP, da Cunha MG, Mazzuco R, Kamamoto C, Cazerta C
Recommendations on the Use of Injectable Poly-L-Lactic Acid for Skin Laxity in Off-Face Areas. J Drugs Dermatol. 2019 Sep 1;18(9):929-935.
Jabbar A, Arruda S, Sadick N
Off Face Usage of Poly-L-Lactic Acid for Body Rejuvenation. J Drugs Dermatol. 2017 May 1;16(5):489-494. Review.
Lin MJ, Dubin DP, Khorasani H
Poly-L-Lactic Acid for Minimally Invasive Gluteal Augmentation. Dermatol Surg. 2020 Mar;46(3):386-394. doi: 10.1097/DSS.0000000000001967. Review.
Mazzuco R, Sadick NS
The Use of Poly-L-Lactic Acid in the Gluteal Area. Dermatol Surg. 2016 Mar;42(3):441-3. doi: 10.1097/DSS.0000000000000632.
Narins RS, Baumann L, Brandt FS, Fagien S, Glazer S, Lowe NJ, Monheit GD, Rendon MI, Rohrich RJ, Werschler WP
A randomized study of the efficacy and safety of injectable poly-L-lactic acid versus human-based collagen implant in the treatment of nasolabial fold wrinkles. J Am Acad Dermatol. 2010 Mar;62(3):448-62. doi: 10.1016/j.jaad.2009.07.040.
Uebel CO, Piccinini PS, Martinelli A, Aguiar DF, Ramos RFM
Cellulite: A Surgical Treatment Approach. Aesthet Surg J. 2018 Sep 14;38(10):1099-1114. doi: 10.1093/asj/sjy028.

A Randomized Single Center, Double Blinded, Split-body Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Cellulite of the Buttocks and Thighs

Details for clinical trial NCT04830722

Clinical trial NCT04830722 - References