Study to Determine Effectiveness of Activation Mist on Facial Skin Wrinkles
A Double-Blind, Randomized, Placebo-controlled Study to Compare the Efficacy and Safety of Rena ™ Activation Mist on Facial Skin Wrinkles.
1 other identifier
interventional
60
1 country
1
Brief Summary
To determine the effect of Activation Mist (AM) on skin wrinkles and appearance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2013
CompletedFirst Posted
Study publicly available on registry
September 11, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedSeptember 11, 2013
September 1, 2013
7 months
September 7, 2013
September 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Silicone skin replica analysis
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 Outcomes (2)
Wrinkle Score
every week for 8 weeks
Photographic evaluation
weekly for 8 weeks
Study Arms (2)
Activation Mist
ACTIVE COMPARATORLiquid mist preparation to be sprayed topically on wrinkle areas
Placebo
PLACEBO COMPARATORsugar pill
Interventions
Eligibility Criteria
You may qualify if:
- Male and female subjects aged 30 to 80 years of age with significant facial wrinkles as assessed by the study physician.
You may not qualify if:
- Women who are pregnant or lactating.
- 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.
- Subjects with clinically significant cardiovascular, neurological, renal, endocrine or hematological abnormalities uncontrolled on current therapy.
- Subjects with history of skin malignancy
- Subjects with signs of recent sunburn
- Use of any of the following medications, within 1 week specified of visit 1
- Systemic steroids
- Topical steroids used on the face
- Topical facial preparations including but not limited to: salicylic acid and other acne products, tacrolimus, pimecrolimus.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
California Allergy and Asthma Medical Group
Los Angeles, California, 90025, United States
Related Links
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2013
First Posted
September 11, 2013
Study Start
November 1, 2013
Primary Completion
June 1, 2014
Study Completion
August 1, 2014
Last Updated
September 11, 2013
Record last verified: 2013-09