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CompletedNCT03508973Updated Apr 26, 2018

Sculptra for Décolletage Crepiness and Wrinkling

An interventional study of Sculpta in Décolletage, sponsored by Skin Laser & Surgery Specialists. Completed. Open to female participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-26.

Sponsored by Skin Laser & Surgery Specialists · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
40 Years to 70 Years
Sex
Female
01

Study summary

The purpose of this study is to evaluate the safety and efficacy of Sculptra as a volume agent to improve décolletage crepiness and wrinkling.

02

Conditions studied

  • Décolletage
03

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Female volunteer
  • Aged from 40-70 years on the day of screening
  • No known medical conditions that may interfere with study participation
  • Moderate to severe crepiness and wrinkling of the décolletage
  • Willingness to not use any products on their décolleté for the duration of the study
  • Read, understand, and sign informed consent forms
  • Willingness to sign photography release form
  • Willing and able to comply with all follow-up requirements
  • Willingness to undergo a series of three Sculptra injections, 2-3 months apart, in their décolletage

Exclusion criteria

Exclusion Criteria:

  • Any significant skin disease at treatment area
  • Any medical condition which could interfere with the treatment
  • Inability or unwillingness to follow the treatment schedule
  • Inability or unwillingness to sign the informed consent
  • History of poor wound healing
  • History of keloid formation
  • History of HIV, hepatitis, immuno-compromised
  • Pregnant or lactating
  • Previous use of deep chemical peels on the treatment area
  • Previous injections of Sculptra in the décolletage
  • Known hypersensitivity to Sculptra or any of its ingredients
  • Previous laser or light based treatments to the treatment area 6 months prior to the screening visit
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Sculptra

    Sculptra, an injectable implant containing microparticles of ply-L-lactic acid, carboxymethylcellulose, non-pyrogenic mannitol and sterile water, will be injected into the decolletage.

    Other: Sculpta

Interventions

  • OtherSculpta
05

What researchers measure

Primary outcomes

  1. Change in décolletage crepiness and wrinkling in treatment area as measured by 5 point décolletage wrinkle scale

    Time frame: Screening, Treatment 1, Treatment 2, Treatment 3, 1 Month Follow up, 3 Month Follow up and 6 Month Follow up

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03508973
Lead sponsor
Skin Laser & Surgery Specialists
Responsible party
David J. Goldberg, MD (David J. Goldberg, MD, JD, Skin Laser & Surgery Specialists) — Principal investigator
First posted
Apr 26, 2018
Start date
Nov 9, 2015
Primary completion
Dec 13, 2016
Completion
Dec 13, 2016
Last update
Apr 26, 2018
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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