Investigation of a Novel Cosmeceutical to Reduce the Visible Signs of Cutaneous Aging

Study Overview
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Brief Summary
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Tomorrowlabs has developed a revolutionary cosmeceutical formulation to rejuvenate aging skin. Tomorrowlabs is conducting this research to study whether this cosmeceutical can reduce the visible signs of cutaneous aging.

Detailed Description
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It is proposed to study a cosmeceutical formulation designed to reduce the visible signs of cutaneous aging. It is expected that daily application of the formulation may minimize wrinkles and fine lines of the face.

Official Title
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Investigation of a Novel Cosmeceutical to Reduce the Visible Signs of Cutaneous Aging - A Randomized Controlled Double Blind Study

Conditions
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Aging

Intervention / Treatment
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* Other: Tomorrowlabs cosmeceutical formulation
* Other: Sham cosmeceutical formulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers who desire to improve their appearance by reducing the visible signs of cutaneous aging in the face Exclusion Criteria: Subjects who have undergone facial plastic surgery or aesthetic dermatology treatments to the face (such as fillers and neuromodulators) in the past 6 months Subjects with a history of collagen vascular disease, cutis laxa, connective tissue disease, psoriasis, or lupus. Subjects diagnosed with scleroderma. Subjects with a body mass index (BMI) > 30. Subjects taking steroid therapy.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Tomorrowlabs cosmeceutical formulation is applied to the face of the subjects twice daily for 3 consecutive months. | Other: Tomorrowlabs cosmeceutical formulation<br> <br> * Other names: HSF Day Catalyst;|
| Sham Comparator: Control<br>Tomorrowlabs cosmeceutical formulation without the active ingredient is applied to the face of the subjects twice daily for 3 consecutive months. | Other: Sham cosmeceutical formulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validated Assessment Scales for Age-related Changes of the Face | A reliable tool for valid and reproducible assessment of the aging process in various face areas will be employed by our independent panel of assessors to scale the primary outcome. (1-3) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin quality assessment | The skin scope uses black light and magnification to show variety of skin imperfections that are undetectable with the naked eye such as dry and thin skin | 3 months | 
| Subject Satisfaction With the Results | Self assessment questionnaire | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cutaneous aging, skin rejuvenation, wrinkles