Skin Wrinkles on Face and Neck AreasNCT01939964
Study to Determine Effectiveness of Activation Mist on Facial Skin Wrinkles
A study testing Activation Mist in people with Skin Wrinkles on Face and Neck Areas, run by California Allergy and Asthma Medical Group, Inc. at 1 site in United States.
Trial summary
To determine the effect of Activation Mist (AM) on skin wrinkles and appearance. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Wrinkles on Face and Neck Areas
- What is being tested?
- Activation Mist
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1.Male and female subjects aged 30 to 80 years of age with significant facial wrinkles as assessed by the study physician.
Who cannot join
- 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
Show all 9Show fewer
- Systemic steroids
- Topical steroids used on the face
- Topical facial preparations including but not limited to: salicylic acid and other acne products, tacrolimus, pimecrolimus.
Trial locations and contacts
1 site in 1 country.
United States1 site
California Allergy and Asthma Medical Group
Los Angeles, California, 90025
Sheldon L Spector, MD, 310-966-9022, spector@calallergy.com
Ricardo A Tan, MD, 310-966-9022, ricardoatan@aol.com
About this study
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.
Read the 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.
- Conditions
- Skin Wrinkles on Face and Neck Areas
- Being tested
- Activation Mist
- Keywords
- Wrinkles, Activation Mist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activation MistOther
Also called AM
Activation Mist topical spray
| Study group | Role | What they receive |
|---|---|---|
| Activation Mist | Active comparator | Liquid mist preparation to be sprayed topically on wrinkle areas Receives: Other: Activation Mist |
| Placebo | Placebo comparator | sugar pill Receives: Other: Activation Mist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before and after 8 weeks of treatment
Secondary outcomes (2)
Wrinkle Score
A blinded evaluation will assess wrinkle appearance and grade on a scale of 0 to 5
Measured: every week for 8 weeks
Photographic evaluation
A blinded evaluator will assess photographs of wrinkles and evaluate presence or absence of improvement
Measured: weekly for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Wrinkles on Face and Neck AreasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California Allergy and Asthma Medical Group, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939964
- Sponsor's protocol ID
- 0012
- Status last verified
- Sep 2013
- First submitted
- 7 Sep 2013
- Last updated
- 11 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-controlled Study to Compare the Efficacy and Safety of Rena ™ Activation Mist on Facial Skin Wrinkles.
- ClinicalTrials.gov ID
- NCT01939964
- Acronym / sponsor ID
- 0012
- Conditions
- Skin Wrinkles on Face and Neck Areas
- Keywords
- Wrinkles, Activation Mist
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- California Allergy and Asthma Medical Group, Inc.University, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 11 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effect of Activation Mist (AM) on skin wrinkles and appearance.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activation Mist | Active comparator | Other: Activation MistLiquid mist preparation to be sprayed topically on wrinkle areas |
| Placebo | Placebo comparator | Other: Activation Mistsugar pill |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Male and female subjects aged 30 to 80 years of age with significant facial wrinkles as assessed by the study physician.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activation MistAlso: AMActivation Mist topical spray | Other | Activation Mist, Placebo |
Primary outcome
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.
2 secondary outcomes
Wrinkle Score
Time frame: every week for 8 weeks
Photographic evaluation
Time frame: weekly for 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2013.
- Research site websiteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
California Allergy and Asthma Medical Group
Los Angeles, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activation Mist in people with Skin Wrinkles on Face and Neck Areas, run by California Allergy and Asthma Medical Group, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Silicone skin replica analysis (time frame: before and after 8 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2013.