Clinical Case Study Evaluating the Efficacy and Tolerability of a Topical Facial Treatment on Healthy Females with Fitzpatrick Skin Types V and VI

NCT ID: NCT06633731

Last Updated: 2024-10-09

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

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-24

Study Completion Date

2024-03-19

Brief Summary

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This single-center, open-label, clinical case 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 on healthy women with Fitzpatrick Skin Types V and VI and mild to moderate global facial radiance, skin smoothness, and overall appearance. The treatment will include an topical facial treatment, biocellulose mask, and post-procedure cream. Furthermore subjects followed a 12 week skincare regimen consisting of a gentle cleanser, bland moisturizer, and bland sunscreen. Eleven (11) healthy female subjects completed the clinical study.

Detailed Description

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This single-center, open-label, clinical case 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 on healthy women with Fitzpatrick Skin Types V and VI and mild to moderate global facial radiance, skin smoothness, and overall appearance. The treatment will include an topical facial treatment, biocellulose mask, and post-procedure cream. Furthermore subjects followed a 12 week skincare regimen consisting of a gentle cleanser, bland moisturizer, and bland sunscreen. The efficacy and tolerability of the topical facial treatment in improving mild to moderate global facial radiance, skin smoothness, and overall appearance 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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Skin Smoothness Radiance Overall Appearance

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. The treatment included a topical treatment, biocellulose mask, and serum. Additionally, subjects followed a 12 weeks skincare regimen including a gentle cleanser, bland moisturizer, and bland sunscreen.

Group Type EXPERIMENTAL

Biocellulose Mask

Intervention Type OTHER

Immediately after treatment, a Biocellulose Mask was applied to the subjects global face for 8 to 10 minutes.

Post Procedure Cream

Intervention Type OTHER

Immediately after treatment and after Biocellulose Mask removal, the Post-Procedure Cream was applied to the subjects global face. Subjects were instructed to apply to the global face from days 1 - 3 post treatment.

Gentle Cleanser

Intervention Type OTHER

Subjects were instructed to wash their face with the Gentle Foaming Cleanser twice daily for 12 weeks.

Facial Moisturizer

Intervention Type OTHER

Subjects were instructed to apply the facial moisturizer twice daily to the global face from day 3 after treatment until next study visit.

sunscreen

Intervention Type OTHER

Subjects were instructed to apply the bland sunscreen to the global face once daily in the morning, with re-application with extended sun exposure per FDA guidelines.

Interventions

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Biocellulose Mask

Immediately after treatment, a Biocellulose Mask was applied to the subjects global face for 8 to 10 minutes.

Intervention Type OTHER

Post Procedure Cream

Immediately after treatment and after Biocellulose Mask removal, the Post-Procedure Cream was applied to the subjects global face. Subjects were instructed to apply to the global face from days 1 - 3 post treatment.

Intervention Type OTHER

Gentle Cleanser

Subjects were instructed to wash their face with the Gentle Foaming Cleanser twice daily for 12 weeks.

Intervention Type OTHER

Facial Moisturizer

Subjects were instructed to apply the facial moisturizer twice daily to the global face from day 3 after treatment until next study visit.

Intervention Type OTHER

sunscreen

Subjects were instructed to apply the bland sunscreen to the global face once daily in the morning, with re-application with extended sun exposure per FDA guidelines.

Intervention Type OTHER

Other Intervention Names

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CMT Post Procedure Cream, Revision Skincare Gentle Foaming Cleanser, Revision Skincare Cetaphil® Sheer Mineral Sunscreen SPF 30

Eligibility Criteria

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Inclusion Criteria

* Individuals with Fitzpatrick Skin Type V and VI
* Individuals with mild to moderate global facial radiance, skin smoothness, and overall appearance (Score 2 - 6 on a 10-point modified Griffiths scale).
* Individuals willing to undergo a washout period of 3 days.

Exclusion Criteria

* Individuals who are nursing (breastfeeding), pregnant, or planning to become pregnant during the study.
* Individuals currently having or having a history of cold sores (Herpes Simplex) on the face.
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tone Dermatology

UNKNOWN

Sponsor Role collaborator

Revision Skincare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tone Dermatology

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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RS-2023-01

Identifier Type: -

Identifier Source: org_study_id

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