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

NCT ID: NCT06629792

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-11

Study Completion Date

2022-05-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fine Lines Wrinkles Laxity; Skin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Topical Treatment

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.

Group Type EXPERIMENTAL

Gentle Cleanser

Intervention Type OTHER

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

Facial Moisturizer

Intervention Type OTHER

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

sunscreen SPF 30

Intervention Type 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.

Interventions

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Gentle Cleanser

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

Intervention Type OTHER

Facial Moisturizer

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

Intervention Type OTHER

sunscreen SPF 30

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.

Intervention Type OTHER

Other Intervention Names

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Gentle Foaming Cleanser, Revision Skincare Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 30

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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SGS Stephens, Inc

UNKNOWN

Sponsor Role collaborator

Revision Skincare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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SGS Stephens, inc.

Richardson, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C22-D008

Identifier Type: -

Identifier Source: org_study_id

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