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Study to Determine Effectiveness of Activation Mist on Facial Skin Wrinkles

NCT ID: NCT01939964

Last Updated: 2013-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-08-31

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.

Conditions

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Skin Wrinkles on Face and Neck Areas

Keywords

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Wrinkles Activation Mist

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Activation Mist

Liquid mist preparation to be sprayed topically on wrinkle areas

Group Type ACTIVE_COMPARATOR

Activation Mist

Intervention Type OTHER

Activation Mist topical spray

Placebo

sugar pill

Group Type PLACEBO_COMPARATOR

Activation Mist

Intervention Type OTHER

Activation Mist topical spray

Interventions

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Activation Mist

Activation Mist topical spray

Intervention Type OTHER

Other Intervention Names

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AM

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

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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California Allergy and Asthma Medical Group, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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California Allergy and Asthma Medical Group

Los Angeles, California, United States

Site Status

Countries

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United States

Facility Contacts

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Sheldon L Spector, MD

Role: primary

Ricardo A Tan, MD

Role: backup

Related Links

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http://www.calallergy.com

Research site website

Other Identifiers

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0012

Identifier Type: -

Identifier Source: org_study_id