Skin Wrinkles on Face and Neck Areas
Conditions
Keywords
Wrinkles, Activation Mist
Brief summary
To determine the effect of Activation Mist (AM) on skin wrinkles and appearance.
Detailed description
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.
Interventions
OTHERActivation Mist
Activation Mist topical spray
Sponsors
California Allergy and Asthma Medical Group, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
Yes
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
1. Women who are pregnant or lactating. 2. 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. 3. Subjects with clinically significant cardiovascular, neurological, renal, endocrine or hematological abnormalities uncontrolled on current therapy. 4. Subjects with history of skin malignancy 5. Subjects with signs of recent sunburn 6. Use of any of the following medications, within 1 week specified of visit 1 1. Systemic steroids 2. Topical steroids used on the face 3. Topical facial preparations including but not limited to: salicylic acid and other acne products, tacrolimus, pimecrolimus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Silicone skin replica analysis | before and after 8 weeks of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wrinkle Score | every week for 8 weeks | A blinded evaluation will assess wrinkle appearance and grade on a scale of 0 to 5 |
| Photographic evaluation | weekly for 8 weeks | A blinded evaluator will assess photographs of wrinkles and evaluate presence or absence of improvement |
Countries
United States
Outcome results
None listed