Study to Determine Effectiveness of Activation Mist on Facial Skin Wrinkles

N/AUnknownNCT01939964

California Allergy and Asthma Medical Group, Inc.60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Skin Wrinkles on Face and Neck Areas

Interventions

Activation MistOTHER

Activation Mist topical spray

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

California Allergy and Asthma Medical Group

Los Angeles, California, United States

Outcomes

Primary Outcomes

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.

Time frame: before and after 8 weeks of treatment

Secondary Outcomes

Wrinkle Score

A blinded evaluation will assess wrinkle appearance and grade on a scale of 0 to 5

Time frame: every week for 8 weeks

Photographic evaluation

A blinded evaluator will assess photographs of wrinkles and evaluate presence or absence of improvement

Time frame: weekly for 8 weeks

Data from ClinicalTrials.gov

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