Study to Determine Effectiveness of Activation Mist on Facial Skin Wrinkles

Not Applicable

• Conditions: Skin Wrinkles on Face and Neck Areas
• Interventions: Other: Activation Mist

• Registration Number: NCT01939964
• Lead Sponsor: California Allergy and Asthma Medical Group, Inc.

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.

Study Timeline

• Status Verified: 2013-09
• Study First Submitted: 2013-09-07
• Study First Submitted QC: 2013-09-07
• Last Update Submitted: 2013-09-07
• Study First Posted: 2013-09-11
• Last Update Posted: 2013-09-11
• Study Start: 2013-11
• Primary Completion: 2014-06
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Activation Mist	Activation Mist	Liquid mist preparation to be sprayed topically on wrinkle areas
Placebo	Activation Mist	sugar pill

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

California Allergy and Asthma Medical Group; 🇺🇸 Los Angeles, California, United States