Study to Determine Effectiveness of Activation Mist on Facial Skin Wrinkles

Study Overview
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Brief Summary
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To determine the effect of Activation Mist (AM) on skin wrinkles and appearance.

Detailed Description
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This study aims to study the effects of Activation Mist ( AM) on skin wrinkles. It contains a proprietary blend of minerals and nutritional supplements which is patented as Liquidized Infrared Negative Ion Activation Energy. Active ingredients include sodium bicarbonate, potassium bicarbonate, sodium carbonate, strontium carbonate, gold nanoparticles, calcium, germanium, selenium , zinc, sugar and water. When applied to the skin , it has been shown to reduce the appearance of wrinkles by stimulation of skin fibroblasts to produce new collagen while removing aging dermis cells, facilitate the production of fibrillin proteins and protect the skin from ultraviolet rays.

Official Title
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A Double-Blind, Randomized, Placebo-controlled Study to Compare the Efficacy and Safety of Rena ™ Activation Mist on Facial Skin Wrinkles.

Conditions
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Skin Wrinkles on Face and Neck Areas

Intervention / Treatment
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* Other: Activation Mist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Male and female subjects aged 30 to 80 years of age with significant facial wrinkles as assessed by the study physician. Exclusion Criteria: Women who are pregnant or lactating. Subjects with skin conditions that are deemed by the investigator to interfere with the results of this study , including but not limited to: uncontrolled acne, rosacea, atopic dermatitis. Subjects with clinically significant cardiovascular, neurological, renal, endocrine or hematological abnormalities uncontrolled on current therapy. Subjects with history of skin malignancy Subjects with signs of recent sunburn Use of any of the following medications, within 1 week specified of visit 1 Systemic steroids Topical steroids used on the face Topical facial preparations including but not limited to: salicylic acid and other acne products, tacrolimus, pimecrolimus.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Activation Mist<br>Liquid mist preparation to be sprayed topically on wrinkle areas | Other: Activation Mist<br>* Activation Mist topical spray<br>* Other names: AM;|
| Placebo Comparator: Placebo<br>sugar pill | Other: Activation Mist<br>* Activation Mist topical spray<br>* Other names: AM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Silicone skin replica analysis | Silflo ™ vinyl silicone ( Cuderm Corp.) is applied to the skin areas to be studied and replicas obtained after letting it stand for 3- 5 minutes. The replica technique takes a negative copy of the skin surface which is analyzed by optical profilometry. Optical profilometry ( BioNet Inc.) uses light intensity to assess skin wrinkle texture by objective parameters ( e.g. spacing, breadth, shadows, num wrinkles) This will be performed before and after 8 weeks of treatment. | before and after 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wrinkle Score | A blinded evaluation will assess wrinkle appearance and grade on a scale of 0 to 5 | every week for 8 weeks | 
| Photographic evaluation | A blinded evaluator will assess photographs of wrinkles and evaluate presence or absence of improvement | weekly for 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wrinkles, Activation Mist