Skin AgingNCT06804772
A Clinical Study to Evaluate the Efficacy of Activated Silk™ 27P-α in Subjects, Aged 35-65 Years of Age, to Improve the Signs of Aging, by Comparing to a Placebo
A study testing Investigational Facial Serum #3, Investigational Facial Serum #1 and Investigational Facial Serum #2 in people with Skin Aging, run by Victoria Collotta at 1 site in United States.
Trial summary
A clinical study with approximately 15 subjects, aged 35-65 years of age, who must have crow's feet and at least one other type of facial fine lines/wrinkles in order to evaluate the efficacy of Activated Silk™ 27P-α to improve the signs of aging, by comparing to a placebo. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- Investigational Facial Serum #3, Investigational Facial Serum #1 and Investigational Facial Serum #2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals, between the ages of 35 - 65 years of age, with no known medical conditions that interfere with study participation, are the priority.
- Subject has signed a written Informed Consent prior to Day -7.
- 100% of subjects have crow's feet and at least one of the following: forehead lines/wrinkles (e.g. vertical lines between eyebrows, horizontal lines above the eyebrow), marionette lines, nasolabial folds.
- 50% of subjects have self-perceived sensitive skin.
- 20% of the subjects are not 100% Caucasian.
Who cannot join
- Subject is pregnant, nursing, or planning to become pregnant.
- Subject is currently using medication likely to affect the response to investigational formulation.
- Subject had a fever in the last 12 hours prior to the start of the study.
- Subject has a pacemaker or significant medical history of hepatic, renal, cardiac, pulmonary, digestive, hematological, neurological, locomotor or psychiatric disease; cancer; multiple sclerosis; high blood pressure; thrombosis; phlebitis; insulin-dependent diabetes; or any such related medical condition(s) that may interfere with the completion of the study.
- The Subject used a form of retinol on their face in the past six months.
- The Subject used any prescription skincare products on their face in the last six months.
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- The Subject has received any laser, chemical peel, or other facial resurfacing treatment such as microdermabrasion, dermablading or microneedling in the past four weeks.
- The Subject received Botox, Dysport, other muscle relaxers or injectable skin fillers in the face during the past six months.
- Subject has a known allergy or sensitivity to any ingredient in the aqueous skincare formulation provided for their use in the trial .
- Subject is currently participating in another study utilizing facial products.
- Subject is blind, visually impaired or decisionally impaired.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Evaluate the Efficacy of Activated Silk™ 27P-α to Improve the Signs of Aging, Part 2
A clinical study with approximately 15 subjects, aged 35-65 years of age, who must have crow's feet and at least one other type of facial fine lines/wrinkles in order to evaluate the efficacy of Activated Silk™ 27P-α to improve the signs of aging, by comparing to a placebo.
- Conditions
- Skin Aging
- Being tested
- Investigational Facial Serum #3, Investigational Facial Serum #1, Investigational Facial Serum #2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Facial Serum #3Other
Investigational Facial Serum #3 is a placebo comparator
Investigational Facial Serum #1Other
Investigational Facial Serum #1 is made with Activated Silk™ 27P-α.
Investigational Facial Serum #2Other
Investigational Facial Serum #2 is made with an active comparator.
| Study group | Role | What they receive |
|---|---|---|
| ~15 subjects, aged 35-65, will receive Investigational Facial Serum #3 | Placebo comparator | Not described Receives: Other: Investigational Facial Serum #3 |
| 0 female subjects, aged 35-65, will receive Investigational Facial Serum #1 | Experimental | Not described Receives: Other: Investigational Facial Serum #1 |
| 0 female subjects, aged 35-65 years of age, will receive Investigation Facial Serum #2 | Active comparator | Not described Receives: Other: Investigational Facial Serum #2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in appearance of fine lines/wrinkles as evaluated by the Principal Investigator using a scale from 0-9
Change in appearance of fine lines/wrinkles for subjects treated with Investigational Facial Serum #3 at Day 28 vs. Day 0
Measured: Day 0 to Day 28
Secondary outcomes (2)
Change in appearance of skin characteristics
Change in surface hydration as measured by the Corneometer for subjects treated with Investigational Facial Serum #3 at Day 14 and Day 28 vs. Day 0
Measured: Day 0 to Day 28
Change in appearance of skin characteristics
Change in transepidermal water loss as measured by the Tewometer for subjects treated with Investigational Facial Serum #3 at Day 14 and Day 28 vs. Day 0.
Measured: Day 0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start3 Dec 2024
- Primary completion3 Jan 2025
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Victoria Collotta
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Victoria Collotta, Evolved By Nature
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804772
- Sponsor's protocol ID
- CLN-SKN02-011
- Status last verified
- Dec 2024
- First submitted
- 16 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Efficacy of Activated Silk™ 27P-α to Improve the Signs of Aging, Part 2
- ClinicalTrials.gov ID
- NCT06804772
- Acronym / sponsor ID
- CLN-SKN02-011
- Conditions
- Skin Aging
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Victoria CollottaIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 3 Feb 2025 (actual)
- 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.
A clinical study with approximately 15 subjects, aged 35-65 years of age, who must have crow's feet and at least one other type of facial fine lines/wrinkles in order to evaluate the efficacy of Activated Silk™ 27P-α to improve the signs of aging, by comparing to a placebo.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ~15 subjects, aged 35-65, will receive Investigational Facial Serum #3 | Placebo comparator | Other: Investigational Facial Serum #3 |
| 0 female subjects, aged 35-65, will receive Investigational Facial Serum #1 | Experimental | Other: Investigational Facial Serum #1 |
| 0 female subjects, aged 35-65 years of age, will receive Investigation Facial Serum #2 | Active comparator | Other: Investigational Facial Serum #2 |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy individuals, between the ages of 35 - 65 years of age, with no known medical conditions that interfere with study participation, are the priority.
- Subject has signed a written Informed Consent prior to Day -7.
- 100% of subjects have crow's feet and at least one of the following: forehead lines/wrinkles (e.g. vertical lines between eyebrows, horizontal lines above the eyebrow), marionette lines, nasolabial folds.
- 50% of subjects have self-perceived sensitive skin.
- 20% of the subjects are not 100% Caucasian.
Key exclusion criteria (11 listed)
- Subject is pregnant, nursing, or planning to become pregnant.
- Subject is currently using medication likely to affect the response to investigational formulation.
- Subject had a fever in the last 12 hours prior to the start of the study.
- Subject has a pacemaker or significant medical history of hepatic, renal, cardiac, pulmonary, digestive, hematological, neurological, locomotor or psychiatric disease; cancer; multiple sclerosis; high blood pressure; thrombosis; phlebitis; insulin-dependent diabetes; or any such related medical condition(s) that may interfere with the completion of the study.
- The Subject used a form of retinol on their face in the past six months.
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 |
|---|---|---|
| Investigational Facial Serum #3Investigational Facial Serum #3 is a placebo comparator | Other | ~15 subjects, aged 35-65, will receive Investigational Facial Serum #3 |
| Investigational Facial Serum #1Investigational Facial Serum #1 is made with Activated Silk™ 27P-α. | Other | 0 female subjects, aged 35-65, will receive Investigational Facial Serum #1 |
| Investigational Facial Serum #2Investigational Facial Serum #2 is made with an active comparator. | Other | 0 female subjects, aged 35-65 years of age, will receive Investigation Facial Serum #2 |
Primary outcome
Change in appearance of fine lines/wrinkles as evaluated by the Principal Investigator using a scale from 0-9
Time frame: Day 0 to Day 28
Change in appearance of fine lines/wrinkles for subjects treated with Investigational Facial Serum #3 at Day 28 vs. Day 0
2 secondary outcomes
Change in appearance of skin characteristics
Time frame: Day 0 to Day 28
Change in appearance of skin characteristics
Time frame: Day 0 to Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Facial Serum #3, Investigational Facial Serum #1 and Investigational Facial Serum #2 in people with Skin Aging, run by Victoria Collotta 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 5 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in appearance of fine lines/wrinkles as evaluated by the Principal Investigator using a scale from 0-9 (time frame: Day 0 to Day 28). 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 3 Feb 2025.