Skin Wrinkles on Face and Neck Areas Clinical Trial
Official title:
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.
| Status | Not yet recruiting |
| Enrollment | 60 |
| Est. completion date | August 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 30 Years to 80 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | California Allergy and Asthma Medical Group | Los Angeles | California |
| Lead Sponsor | Collaborator |
|---|---|
| California Allergy and Asthma Medical Group, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Wrinkle Score | A blinded evaluation will assess wrinkle appearance and grade on a scale of 0 to 5 | every week for 8 weeks | No |
| Secondary | Photographic evaluation | A blinded evaluator will assess photographs of wrinkles and evaluate presence or absence of improvement | weekly for 8 weeks | No |