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

NCT06629792 | Completed

• 1 other identifier: C22-D008
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fine Lines; Wrinkles; Laxity; Skin

Keywords

topical treatment; skin rejuvenation; anti-aging

Outcome Measures

Primary Outcomes (3)

• Change Investigator Clinical Efficacy Grading versus Baseline

  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.

  12 weeks

• Lack of significant change in Investigator Tolerability Parameters versus Baseline

  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.

  12 weeks

• Lack of significant change in Subjective Tolerability versus Baseline

  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.

  12 weeks

Secondary Outcomes (2)

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

  12 weeks

• Clinical Photography: VISIA-CR and Antera 3D

  12 weeks

Study Arms (1)

Topical Treatment

EXPERIMENTAL

Subjects received a topical facial treatment applied by a license esthetician in a series of 3 sessions at 1 month intervals, in combination with a cleanser, moisturizer, and sunscreen over the course of 12 weeks.

Other: Gentle Cleanser; Other: Facial Moisturizer; Other: sunscreen SPF 30

Interventions

Gentle Cleanser OTHER

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

Also known as: Gentle Foaming Cleanser, Revision Skincare

Topical Treatment

Facial Moisturizer OTHER

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

Topical Treatment

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.

Also known as: Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 30

Topical Treatment

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Revision Skincare: lead
• SGS Stephens, Inc: collaborator

Study Sites (1)

SGS Stephens, inc.

Richardson, Texas, 75081, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: January 11, 2022
• Primary Completion: May 5, 2022
• Study Completion: May 5, 2022
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)