Clincosm LogoSign in Get a demo

Study to Determine Effectiveness of Activation Mist on Facial Skin Wrinkles

Sponsor
California Allergy and Asthma Medical Group, Inc. (Other)
Overall Status
Unknown status
CT.gov ID
NCT01939964
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
9
Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Activation Mist
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Double-Blind, Randomized, Placebo-controlled Study to Compare the Efficacy and Safety of Rena ™ Activation Mist on Facial Skin Wrinkles.
Study Start Date :
Nov 1, 2013
Anticipated Primary Completion Date :
Jun 1, 2014
Anticipated Study Completion Date :
Aug 1, 2014

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Wrinkle Score [every week for 8 weeks]

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

    2. Photographic evaluation [weekly for 8 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    7. Systemic steroids

    8. Topical steroids used on the face

    9. Topical facial preparations including but not limited to: salicylic acid and other acne products, tacrolimus, pimecrolimus.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 California Allergy and Asthma Medical Group Los Angeles California United States 90025

    Sponsors and Collaborators

    • California Allergy and Asthma Medical Group, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    California Allergy and Asthma Medical Group, Inc.
    ClinicalTrials.gov Identifier:
    NCT01939964
    Other Study ID Numbers:
    • 0012
    First Posted:
    Sep 11, 2013
    Last Update Posted:
    Sep 11, 2013
    Last Verified:
    Sep 1, 2013
    Keywords provided by California Allergy and Asthma Medical Group, Inc.
    Wrinkles
    Activation Mist

    Study Results

    No Results Posted as of Sep 11, 2013