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OpenTrials
Completed

NCT Number: NCT03508973

Sculptra for Décolletage Crepiness and Wrinkling

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

Completed

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Key information

Conditions

Décolletage

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Sculpta

Other

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

Sponsors and collaborators

Lead sponsor

Skin Laser & Surgery Specialists

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 26, 2018
Registry last updated
Apr 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.