Clinical trial NCT06633731: Clinical Case Study Evaluating the Efficacy and Tolerability of a Topical Facial Treatment on Healthy Females with Fitzpatrick Skin Types V and VI
Official title: Clinical Case Study Evaluating the Efficacy and Tolerability of a Topical Facial Treatment on Healthy Females with Fitzpatrick Skin Types V and VI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Smoothness
Radiance
Overall Appearance
Keywords: anti-aging
Fitzpatrick Skin Types V and VI
Skin Rejuvenation
Lead sponsor: Revision Skincare
Sponsor class: INDUSTRY
Collaborators: name: Tone Dermatology
First posted: 2024-10-09
Enrollment: 11
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Investigator Clinical Efficacy Grading versus Baseline
timeFrame: 12 weeks
measure: Lack of Significant Change in Investigator Tolerability Parameters versus Baseline
timeFrame: 12 weeks
measure: Lack of Significant Change in Subjective Tolerability versus Baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Clinical Photography: VISIA-CR and Antera 3D
timeFrame: 12 weeks
measure: Change in Facial Parameters in a Self-Assessment Questionnaire versus Baseline and Percent Agreement
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Tone Dermatology
state: Illinois
Study officials:
References: