Facial WrinklesNCT07850817
Anti-Wrinkle Efficacy of a Syringic Acid-Containing Emulsion
A study testing Synox-containing Emulsion in people with Facial Wrinkles and Skin Aging, run by BioSpectrum Inc at 1 site in South Korea.
Trial summary
This randomized, double-blind, split-face controlled study was conducted to evaluate the anti-wrinkle efficacy and safety of a Syringic acid-containing emulsion in healthy female subjects. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Wrinkles, Skin Aging
- What is being tested?
- Synox-containing Emulsion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jan 2015to 17 Apr 2015
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 30 to 65 years with facial wrinkles at the test site according to investigator assessment.
- Healthy subjects without acute or chronic systemic diseases, including skin diseases.
- Subjects who voluntarily agreed to participate after receiving sufficient explanation of the study purpose and procedures and provided written informed consent.
- Subjects who were able to comply with study procedures and follow-up visits.
Who cannot join
- Subjects who were pregnant, breastfeeding, or planning pregnancy within 6 months.
- Subjects who had used topical products containing steroids for treatment of skin diseases for more than one month.
- Subjects who participated in similar clinical studies within 6 months.
- Subjects with sensitive or hypersensitive skin.
- Subjects with abnormal skin conditions at the test site, including moles, warts, or telangiectasia.
- Subjects who had used similar cosmetics or medicines within 3 months before study initiation.
Show all 9Show fewer
- Subjects who received or planned cosmetic procedures (e.g., skin peeling, Botox, or other dermatological treatments) within 6 months.
- Subjects with chronic wasting diseases or systemic diseases.
- Subjects considered unsuitable for participation by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Split-Face Controlled Study to Evaluate the Anti-Wrinkle Efficacy and Safety of a Syringic Acid-Containing Emulsion in Healthy Subjects
This randomized, double-blind, split-face controlled study was conducted to evaluate the anti-wrinkle efficacy and safety of a Syringic acid-containing emulsion in healthy female subjects.
The test product was an emulsion containing 2% Synox, a Syringic acid-containing ingredient, while the control product was an emulsion without Synox. Participants applied the test and control products to opposite sides of the face according to random allocation for 12 weeks.
Skin wrinkle-related parameters were evaluated at baseline and after 4, 8, and 12 weeks of product use using visual assessment, replica-based instrumental measurement, and subject questionnaires. Skin safety was monitored throughout the study period.
Read the detailed description
Skin aging is associated with the formation of facial wrinkles and changes in skin surface characteristics. This study was designed to evaluate the anti-wrinkle efficacy and safety of a Syringic acid-containing emulsion using a randomized, double-blind, split-face controlled clinical trial design.
Healthy female subjects with facial wrinkles were enrolled in this study. Participants were randomly assigned to treatment groups and applied the test product containing 2% Synox and the control product without Synox to opposite sides of the face according to the assigned allocation.
The products were applied twice daily for 12 weeks. Evaluations were performed before product use and after 4, 8, and 12 weeks of application. Anti-wrinkle efficacy was assessed through visual evaluation, replica-based instrumental analysis of wrinkle parameters, and questionnaire evaluation. Safety assessments were conducted throughout the study period.
Synox is a Syringic acid-containing ingredient, and the final test formulation contained Synox at 2%.
- Conditions
- Facial Wrinkles, Skin Aging
- Being tested
- Synox-containing Emulsion, Control Emulsion
- Keywords
- Anti-wrinkle, Syringic acid, Synox, Split-face study, Cosmetic emulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synox-containing EmulsionOther
A cosmetic emulsion containing 2% Synox, a raw material containing 1% Syringic acid, was applied topically for 12 weeks.
Control EmulsionOther
A vehicle control emulsion without Synox was applied to the contralateral side of the face for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Test Emulsion Right / Control Emulsion Left | Experimental | Participants in Group A applied the test emulsion containing Synox on the right side of the face and the control emulsion on the left side of the face according to the randomized split-face allocation. Receives: Other: Synox-containing Emulsion; Other: Control Emulsion |
| Test Emulsion Left / Control Emulsion Right | Experimental | Participants in Group B applied the test emulsion containing Synox on the left side of the face and the control emulsion on the right side of the face according to the randomized split-face allocation. Receives: Other: Synox-containing Emulsion; Other: Control Emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Skin Roughness (Rt) (a.u.) After Application of Synox-Containing Emulsion
Skin roughness (Rt) was assessed from SILFLO skin replicas using a Visioline® VL650 (C+K, Germany). Skin replicas were prepared from the wrinkle-prone test area and analyzed by the instrument to obtain skin surface roughness parameters. Rt was expressed in arbitrary units (a.u.). Changes in Rt from baseline were assessed at Weeks 4, 8, and 12 and compared between the Synox-containing emulsion-treated side and the control emulsion-treated side.
Measured: Baseline, Week 4, Week 8, and Week 12
Secondary outcomes (2)
Change in Maximum Skin Roughness (Rm) (a.u.) After Application of Synox-Containing Emulsion
Maximum skin roughness (Rm) was assessed from SILFLO skin replicas using a Visioline® VL650 (C+K, Germany). Skin replicas were prepared from the wrinkle-prone test area and analyzed by the instrument to obtain skin surface roughness parameters. Rm was expressed in arbitrary units (a.u.). Changes in Rm from baseline were assessed at Weeks 4, 8, and 12 and compared between the Synox-containing emulsion-treated side and the control emulsion-treated side.
Measured: Baseline, Week 4, Week 8, and Week 12
Change in Periorbital Wrinkle Assessment Grade After Application of Synox-Containing Emulsion
Periorbital wrinkles were evaluated by two independent evaluators according to modified Danielle's criteria. Wrinkle severity was graded on a 0-9 scale in 0.5-point increments, with higher scores indicating greater wrinkle severity. Facial images of the periorbital area were obtained using the VISIA® ver. 5 imaging system (Canfield, USA). The wrinkle grade was recorded at each assessment time point, and the mean grade was used for analysis. Changes in wrinkle assessment grade from baseline were assessed at Weeks 4, 8, and 12 and compared between the Synox-containing emulsion-treated side and the control emulsion-treated side.
Measured: Baseline, Week 4, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start12 Jan 2015
- Primary completion17 Apr 2015
- Study completion17 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial WrinklesStudies 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
- Model description
- This study was conducted using a randomized split-face controlled design. Participants were assigned to two groups and applied the test product and control product to opposite sides of the face according to the randomized allocation scheme.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioSpectrum Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850817
- Sponsor's protocol ID
- DPE-HSWIT001(1)-15001
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Split-Face Controlled Study to Evaluate the Anti-Wrinkle Efficacy and Safety of a Syringic Acid-Containing Emulsion in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07850817
- Acronym / sponsor ID
- DPE-HSWIT001(1)-15001
- Conditions
- Facial Wrinkles, Skin Aging
- Keywords
- Anti-wrinkle, Syringic acid, Synox, Split-face study, Cosmetic emulsion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- BioSpectrum IncIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2015 (actual)
- Primary completion
- 17 Apr 2015 (actual)
- Study completion
- 17 Apr 2015 (actual)
- First posted
- 30 Sep 2026 (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.
This randomized, double-blind, split-face controlled study was conducted to evaluate the anti-wrinkle efficacy and safety of a Syringic acid-containing emulsion in healthy female subjects.
The test product was an emulsion containing 2% Synox, a Syringic acid-containing ingredient, while the control product was an emulsion without Synox. Participants applied the test and control products to opposite sides of the face according to random allocation for 12 weeks.
Skin wrinkle-related parameters were evaluated at baseline and after 4, 8, and 12 weeks of product use using visual assessment, replica-based instrumental measurement, and subject questionnaires. Skin safety was monitored throughout the study period.
Detailed description
Skin aging is associated with the formation of facial wrinkles and changes in skin surface characteristics. This study was designed to evaluate the anti-wrinkle efficacy and safety of a Syringic acid-containing emulsion using a randomized, double-blind, split-face controlled clinical trial design.
Healthy female subjects with facial wrinkles were enrolled in this study. Participants were randomly assigned to treatment groups and applied the test product containing 2% Synox and the control product without Synox to opposite sides of the face according to the assigned allocation.
The products were applied twice daily for 12 weeks. Evaluations were performed before product use and after 4, 8, and 12 weeks of application. Anti-wrinkle efficacy was assessed through visual evaluation, replica-based instrumental analysis of wrinkle parameters, and questionnaire evaluation. Safety assessments were conducted throughout the study period.
Synox is a Syringic acid-containing ingredient, and the final test formulation contained Synox at 2%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study was conducted using a randomized split-face controlled design. Participants were assigned to two groups and applied the test product and control product to opposite sides of the face according to the randomized allocation scheme.
| Arm | Type | Receives |
|---|---|---|
| Test Emulsion Right / Control Emulsion Left | Experimental | Other: Synox-containing Emulsion, Other: Control EmulsionParticipants in Group A applied the test emulsion containing Synox on the right side of the face and the control emulsion on the left side of the face according to the randomized split-face allocation. |
| Test Emulsion Left / Control Emulsion Right | Experimental | Other: Synox-containing Emulsion, Other: Control EmulsionParticipants in Group B applied the test emulsion containing Synox on the left side of the face and the control emulsion on the right side of the face according to the randomized split-face allocation. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 30 to 65 years with facial wrinkles at the test site according to investigator assessment.
- Healthy subjects without acute or chronic systemic diseases, including skin diseases.
- Subjects who voluntarily agreed to participate after receiving sufficient explanation of the study purpose and procedures and provided written informed consent.
- Subjects who were able to comply with study procedures and follow-up visits.
Key exclusion criteria (9 listed)
- Subjects who were pregnant, breastfeeding, or planning pregnancy within 6 months.
- Subjects who had used topical products containing steroids for treatment of skin diseases for more than one month.
- Subjects who participated in similar clinical studies within 6 months.
- Subjects with sensitive or hypersensitive skin.
- Subjects with abnormal skin conditions at the test site, including moles, warts, or telangiectasia.
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 |
|---|---|---|
| Synox-containing EmulsionA cosmetic emulsion containing 2% Synox, a raw material containing 1% Syringic acid, was applied topically for 12 weeks. | Other | Test Emulsion Left / Control Emulsion Right, Test Emulsion Right / Control Emulsion Left |
| Control EmulsionA vehicle control emulsion without Synox was applied to the contralateral side of the face for 12 weeks. | Other | Test Emulsion Left / Control Emulsion Right, Test Emulsion Right / Control Emulsion Left |
Primary outcome
Change in Skin Roughness (Rt) (a.u.) After Application of Synox-Containing Emulsion
Time frame: Baseline, Week 4, Week 8, and Week 12
Skin roughness (Rt) was assessed from SILFLO skin replicas using a Visioline® VL650 (C+K, Germany). Skin replicas were prepared from the wrinkle-prone test area and analyzed by the instrument to obtain skin surface roughness parameters. Rt was expressed in arbitrary units (a.u.). Changes in Rt from baseline were assessed at Weeks 4, 8, and 12 and compared between the Synox-containing emulsion-treated side and the control emulsion-treated side.
2 secondary outcomes
Change in Maximum Skin Roughness (Rm) (a.u.) After Application of Synox-Containing Emulsion
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in Periorbital Wrinkle Assessment Grade After Application of Synox-Containing Emulsion
Time frame: Baseline, Week 4, Week 8, and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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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 Synox-containing Emulsion in people with Facial Wrinkles and Skin Aging, run by BioSpectrum Inc at 1 site in South Korea.
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 4 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: finished, as of the sponsor's last update on 30 Sep 2026. 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 South Korea. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Skin Roughness (Rt) (a.u.) After Application of Synox-Containing Emulsion (time frame: Baseline, Week 4, Week 8, and Week 12). 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 30 Sep 2026.