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Completed

NCT Number: NCT03780244

Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.

This study has been designed to evaluate the safety of Sculptra Aesthetic as a single regimen for correction of Nasolabial Fold (NLF) contour deficiencies after changes in reconstitution and injection procedures compared to the approved label.

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Key information

Conditions

Nasolabial Folds

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Galderma Study Site, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Intent to undergo correction of both left and right NLFs with a Wrinkle Assessment Scale (WAS) score of greater than or equal to 2 (shallow wrinkles) to less than or equal to 4 (deep wrinkles) as assessed on Day 1 (and also at screening, if screening was performed prior to Day 1) by the Blinded Evaluator. A one grade difference between sides is allowed at inclusion.

Exclusion criteria

  • Previous tissue augmenting therapy, contouring or revitalization treatment in or near the treatment area with any filler prior to Baseline visit.
  • Collagen, Hyaluronic Acid- 12 months
  • Calcium Hydroxyapatite (CaHa), Poly-L-lactic Acid (PLLA) or permanent (non-biodegradable)- Prohibited
  • Known/previous allergy or hypersensitivity to any of the Sculptra Aesthetic constituents.

Treatment and study plan

Sculptra Aesthetic 8ml

Device

Treatment of nasolabial folds

Sculptra Aesthetic 5ml

Device

Treatment of nasolabial folds

Primary outcomes

  1. Change in Wrinkle Assessment Scale (WAS) Score

    Time frame: 48 weeks

    The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator at defined timepoints and not on a comparison to the baseline appearance.

    Effectiveness is defined as change from baseline on both sides of the face using WAS at 48 Weeks after the first treatment session.

Secondary outcomes

  1. Change in Wrinkle Assessment Scale (WAS) Score

    Time frame: Weeks 16, 24, 32, and 40

    The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of NLF wrinkle severity (grades 0-5, with 0 representing no wrinkles and 5 representing very deep wrinkles, redundant fold) was based on visual live assessment by the Blinded Evaluator at defined timepoints and not on a comparison to the baseline appearance.

    Effectiveness is defined as change from baseline on both sides of the face as assessed by the Blinded Evaluator using WAS at X weeks

  2. Responder Rate Based on Global Aesthetic Improvement Scale, Subject Assessment

    Time frame: Weeks 16, 24, 32, 40, and 48.

    Responders defined as at least "improved" (improved, much improved, very much improved) as assessed by the subject

  3. Responder Rate Based on the Global Aesthetic Improvement Scale, Treating Investigator Assessment

    Time frame: Weeks 16, 24, 32, 40 and 48

    Responders defined as at least "improved" (improved, much improved, very much improved) as assessed by the Treating Investigator

  4. FACE-Q Appraisal of Lines Rasch Transformed Total Scores: NLF Questionnaire

    Time frame: Baseline and at weeks 24, 32, 40 and 48

    Subjects' satisfaction using the validated FACE-Q Scale, Rasch-transformed total score (0-100) according to the FACE-Q manual; the higher total score indicated greater subject satisfaction

  5. Satisfaction With Treatment: Does the Treatment Make You Look Younger?

    Time frame: Week 16, 24, 32, 40 and 48

    A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.

  6. Subject Satisfaction With Treatment: Does the Treatment Improve Your Attractiveness?

    Time frame: Week 16, 24, 32, 40 and 48

    A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.

  7. Subject Satisfaction With Treatment; Does the Treatment Make You Feel Better About Yourself?

    Time frame: Week 16, 24, 32, 40 and 48

    A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.

  8. Subject Satisfaction With Treatment: Does the Treatment Improve Your Self-confidence?

    Time frame: Week 16, 24, 32, 40 and 48

    A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.

  9. Subject Satisfaction With Treatment: Does the Treatment Improve Overall Satisfaction With Your Appearance?

    Time frame: Week 16, 24, 32, 40 and 48

    A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.

  10. Subject Satisfaction With Treatment: Does the Treatment Make You Look/Feel More Confident in Your Life?

    Time frame: Week 16, 24, 32, 40 and 48

    A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.

  11. Subject Satisfaction With Treatment: Does the Treatment Make You Look the Way You Feel?

    Time frame: Week 16, 24, 32, 40 and 48

    A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.

  12. Subject Satisfaction With Treatment: Does the Treatment Improve Your Facial Symmetry/Balance?

    Time frame: Week 16, 24, 32, 40 and 48

    A 5-point subject satisfaction questionnaire with the following responses: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied.

  13. Subject Satisfaction With Treatment: Would You Say the Subtle Treatment Results Over Time Was Worth it?

    Time frame: Week 16, 24, 32, 40 and 48

    A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree.

  14. Subject Satisfaction With Treatment: Would You Say the Treatment Results Are Natural Looking?

    Time frame: Week 16, 24, 32, 40 and 48

    A 5-point subject satisfaction questionnaire with the following responses: Strongly Agree, Agree, Neither Agree Nor Disagree, Disagree, Strongly Disagree.

  15. Subject Satisfaction With Treatment: Would You do the Treatment Again?

    Time frame: Week 16, 24, 32, 40 and 48

    A subject satisfaction question with responses Yes or No.

  16. Subject Satisfaction With Treatment: Would You Recommend the Treatment to a Friend?

    Time frame: Week 16, 24, 32, 40 and 48

    A subject satisfaction question with responses Yes or No.

  17. Earliest Time the Subject Reported Feeling Comfortable Returning to Social Engagement Based on Subject Diary Reporting

    Time frame: time in hours from treatment procedure after treatments 1,2,3 and 4 at weeks 0, 4, 8, and 12

    Subjects were asked to complete the following questions in the subject diary:

    • Did you feel comfortable to return to social engagement today? (Yes or No)
    • If yes, what was the earliest time you felt comfortable to return to social engagement? (Record date and time [using 24-hour clock])

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Randomized, Evaluator-blinded, Multi-center Study to Evaluate the Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds.

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 19, 2018
Registry last updated
Nov 14, 2022

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

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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.

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