Study to Determine Effectiveness of Activation Mist on Facial Skin Wrinkles

September 7, 2013 updated by: California Allergy and Asthma Medical Group, Inc.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • California Allergy and Asthma Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Activation Mist
Liquid mist preparation to be sprayed topically on wrinkle areas
Other: Activation Mist
Activation Mist topical spray
Other Names:
  • AM
PLACEBO_COMPARATOR: Placebo
sugar pill
Other: Activation Mist
Activation Mist topical spray
Other Names:
  • AM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Silicone skin replica analysis
Time Frame: 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.
before and after 8 weeks of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Allergy and Asthma Medical Group, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ANTICIPATED)

June 1, 2014

Study Completion (ANTICIPATED)

August 1, 2014

Study Registration Dates

First Submitted

September 7, 2013

First Submitted That Met QC Criteria

September 7, 2013

First Posted (ESTIMATE)

September 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 11, 2013

Last Update Submitted That Met QC Criteria

September 7, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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