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Completed

NCT Number: NCT06629792

A Clinical Study Evaluating the Efficacy and Tolerability of a Topical Facial Treatment For Facial Rejuvenation

This single-center clinical trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals, in combination with a cleanser, moisturizer, and sunscreen over the course of 12 weeks in healthy women aged 35 to 60 with mild to moderate global facial fine lines, wrinkles, and laxity. Thirty-two (32) healthy female subjects completed the clinical study.

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Key information

Conditions

Fine Lines Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Genetic Diseases, Inborn Laxity; Skin Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Wrinkles

Age range

35 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

SGS Stephens, inc.

Richardson, Texas, 75081, United States

About this study

This single-center clinical trial was conducted to evaluate the efficacy and tolerability of a topical facial treatment when applied by a license esthetician in clinic in a series of 3 sessions with 1 month intervals, in combination with a cleanser, moisturizer, and sunscreen over the course of 12 weeks in healthy women aged 35 to 60 with mild to moderate global facial fine lines, wrinkles, and laxity.

The efficacy and tolerability of the topical facial treatment in improving mild to moderate global facial fine lines, wrinkles, and laxity. was evaluated by Investigator clinical efficacy grading and tolerability grading by a board-certified dermatologist, subject tolerability grading, and clinical photography.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Having Fitzpatrick Skin Type I - VI
  • Having mid to moderate global face fine lines, wrinkles, and laxtiy (tactile) (score of 3 to 6 according to a modified Griffiths scale).

Exclusion criteria

  • Breastfeeding, pregnant, or planning to become pregnant during the study.
  • Currently having or having a history of cold sores (Herpes simplex) on the face.

Treatment and study plan

Gentle Cleanser

Other

The cleanser was instructed to be used twice daily over the course of 12 weeks

Other names: Gentle Foaming Cleanser, Revision Skincare

Facial Moisturizer

Other

The Moisturizer was instructed to be applied to the global face twice daily over the course of 12 weeks.

sunscreen SPF 30

Other

The Sunscreen was instructed to be applied once daily in the morning, with re-application with extended sun exposure per FDA guidelines over the course of 12 weeks.

Other names: Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 30

Primary outcomes

  1. Change Investigator Clinical Efficacy Grading versus Baseline

    Time frame: 12 weeks

    The primary efficacy endpoint will be Investigator Clinical Efficacy grading of parameters at baseline, post-application, and weeks 4, 8, and 12. the efficacy parameters will be assessed by the expert grader on each subjects global face using a modified Griffiths 10-point scale. A decrease in score indicates an improvement.

  2. Lack of significant change in Investigator Tolerability Parameters versus Baseline

    Time frame: 12 weeks

    The primary tolerability endpoint will be Investigator Tolerability Assessment of at baseline, post-application, and weeks 4, 8, and 12. Local cutaneous tolerability will be evaluated by the expert grader by assessing the signs of erythema and dryness using a four-point scale: 0 = None 1 = Mild 2 = Moderate 3 = Severe. A decrease in score indicates an improvement.

  3. Lack of significant change in Subjective Tolerability versus Baseline

    Time frame: 12 weeks

    The primary tolerability endpoint will be Subjective Tolerability Assessment of at baseline, post-application, and weeks 4, 8, and 12. Local cutaneous tolerability will be evaluated by subject reporting of the degree of burning, stinging, and itching globally on each subject's global face using a four-point scale: 0 = None 1 = Mild 2 = Moderate 3 = Severe. A decrease in score indicates an improvement.

Secondary outcomes

  1. Change in Facial Parameters in a Self-Assessment Questionnaire versus Baseline and Percent Agreement

    Time frame: 12 weeks

    The secondary endpoint will be subject self-assessment questionnaire completed at baseline, post-application, and weeks 4, 8, and 12. Subjects are asked to rate statements based on a scoring system ranging from 5 (completely agree) to 1 (completely disagree). A change in response values at post-application, and weeks 4, 8, and 12 compared to baseline response values indicates an improvement. The best outcome is to Completely Agree with the statement / question being asked.

  2. Clinical Photography: VISIA-CR and Antera 3D

    Time frame: 12 weeks

    The secondary endpoint will be image analysis of VISIA-CR and Antera 3D clinical photography. VISIA-CR imaging analysis for nasolabial folds, and Antera imaging analysis of roughness and volume on images taken at all timepoints. a reduction in visual fine lines, wrinkles, radiance, and laxity on post-baseline timepoints compared to baseline is indicated an improvement

Sponsors and collaborators

Lead sponsor

Revision Skincare

Industry

Collaborators

  • SGS Stephens, Inc

Registry information

Official study title

A Clinical Study To Evaluate the Efficacy and Tolerance of a Topical Facial Treatment on Women With Mild to Moderate Fine Lines, Wrinkles, and Laxity on the Global Face

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

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.

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