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Study to Determine Effectiveness of Activation Mist on Facial Skin Wrinkles

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ClinicalTrials.gov Identifier: NCT01939964
Recruitment Status : Unknown
Verified September 2013 by California Allergy and Asthma Medical Group, Inc..
Recruitment status was:  Not yet recruiting
First Posted : September 11, 2013
Last Update Posted : September 11, 2013
Sponsor:
Information provided by (Responsible Party):
California Allergy and Asthma Medical Group, Inc.

Study Description
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Brief Summary:
To determine the effect of Activation Mist (AM) on skin wrinkles and appearance.

Condition or disease Intervention/treatment Phase
Skin Wrinkles on Face and Neck Areas Other: Activation Mist Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : August 2014
Arms and Interventions
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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 Name: AM
Placebo Comparator: Placebo
sugar pill
 Other: Activation Mist
Activation Mist topical spray
Other Name: AM


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Photographic evaluation [ Time Frame: weekly for 8 weeks ]
    A blinded evaluator will assess photographs of wrinkles and evaluate presence or absence of improvement


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939964


Locations
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United States, California
California Allergy and Asthma Medical Group
Los Angeles, California, United States, 90025
Contact: Sheldon L Spector, MD    310-966-9022    spector@calallergy.com   
Contact: Ricardo A Tan, MD    310-966-9022    ricardoatan@aol.com   
Principal Investigator: Sheldon L Spector, MD         
Sub-Investigator: Ricardo A Tan, MD         
Sponsors and Collaborators
California Allergy and Asthma Medical Group, Inc.
More Information
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Additional Information:

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Responsible Party: California Allergy and Asthma Medical Group, Inc.
ClinicalTrials.gov Identifier: NCT01939964    
Other Study ID Numbers: 0012
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: September 11, 2013
Last Verified: September 2013
Keywords provided by California Allergy and Asthma Medical Group, Inc.:
Wrinkles
Activation Mist