Face PhotoagingNCT03425955
Aesthetic Performance of an Intradermal Injection Treatment for Face Photoaging: Interstitial or Cushion Technique in Comparison to Bolus Technique at Five Points (Half - Face Method Within Subjects)
A study testing SUNEKOS ® 200 and "SUNEKOS® 1200" and "SUNEKOS® 200" in people with Face Photoaging, run by Derming SRL at 1 site in Italy.
Trial summary
Aesthetic performance of "SUNEKOS® 200" injectable treatment on main sign of face skin aging in normotypic or overweight subjects with rounded, oval or squared face and in thin subjects with oval or triangular face and "sagging" skin.Interstitial or cushion technique in comparison to bolus technique at five points… Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Face Photoaging
- What is being tested?
- SUNEKOS ® 200 and "SUNEKOS® 1200" and "SUNEKOS® 200"
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 19 Oct 2017to 21 Dec 2017
- 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 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female sex,
- age 35-50 years for the group 1 and 45-60 years for the group 2,
- mild/moderate cutaneous photoaging according to a reference photographic scale
- skin phototype I, II and III according to Fitzpatrick's classification, with a preference to grade II-III ,
- agreeing to present at each study visit without make-up,
- accepting to not change their habits regarding food, physical activity, make-up use, face cosmetic and cleansing products,
- accepting not to expose their face to strong UV irradiation (UV session, or sun bathes), during the entire duration of the study,
- accepting to sign the informed consent form.
Who cannot join
- Pregnancy,
- lactation,
- subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study,
- subjects not in menopause who do not accept to perform the pregnancy test during the basal visit, 30 days (T4i) and 60 days (T60) after the first injection procedure,
- Body Mass Index (BMI) variation (± 1) during the study period,
- performing skin treatments for aesthetic correction (biomaterials implants, face lifting, botox injections, laser, chemical peeling) in the 12 months prior to the study start;
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- performing permanent filler in the past,
- change in the normal habits regarding food, physical activity, face cosmetic, cleansing and make-up use during the month preceding the test,
- sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit),
- subjects whose insufficient adhesion to the study protocol is foreseeable,
- presence of cutaneous disease on the tested area, as lesions, scars, malformations,
- recurrent facial/labial herpes,
- clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.).
- diabetes,
- endocrine disease,
- hepatic disorder,
- renal disorder,
- cardiac disorder,
- pulmonary disease,
- cancer,
- neurological or psychological disease,
- inflammatory/immunosuppressive disease,
- drug allergy,
- anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago);
- using of drugs able to influence the test results in the investigator opinion. The use of other drugs, not mentioned above, can be authorized by the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Aesthetic performance of "SUNEKOS® 200" injectable treatment on main sign of face skin aging in normotypic or overweight subjects with rounded, oval or squared face and in thin subjects with oval or triangular face and "sagging" skin.Interstitial or cushion technique in comparison to bolus technique at five points (half - face method within subjects).
Read the detailed description
Spontaneous, open, clinical trial, conducted by one centre under dermatological control. Primary end point of the study was to evaluate clinically and by non-invasive instrumental measurements the aesthetic performance of "SUNEKOS® 200" injectable treatment on main sign of face skin aging in normotypic or overweight subjects with rounded, oval or squared face and in thin subjects with oval or triangular face and "sagging" skin.
The micro-injections of the study product were executed by a specialized dermatologist, on the face of female volunteers with photoaging of mild/moderate grade; to improve the treatment aesthetic performance two different injection techniques were carried out mono-laterally on the left or right face side randomly: "interstitial fluid technique" (IFT) for the 1st subjects' typology (aged 35-50 years) and "cushion technique" in association to "retrograde interstitial fluid technique" (RIFT) for the 2nd (aged 45-60). On the contralateral face side the injection treatment was performed by bolus technique on five pre-determined face points, preceding for the 2nd subjects' typology by cushion technique.
It was also aim of this study to evaluate tolerance both by investigator and volunteers and efficacy by the volunteers
- Conditions
- Face Photoaging
- Being tested
- SUNEKOS ® 200, "SUNEKOS® 1200" and "SUNEKOS® 200"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUNEKOS ® 200Device
4 micro-injection sessions of "SUNEKOS® 200" with an interval of 10 days. Two different injection techniques were carried out mono-laterally on the left or right face side randomly: "interstitial fluid technique" (IFT) on one face side; bolus technique on five pre-determined face points (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) on the contralateral face side.
"SUNEKOS® 1200" and "SUNEKOS® 200"Device
5 micro-injection sessions (one of the product "SUNEKOS® 1200" and four of "SUNEKOS® 200". "SUNEKOS® 1200" was injected bi-laterally on the face with cushion technique. 24 hours after the "SUNEKOS® 1200" treatment, 4 micro-injection sessions of "SUNEKOS® 200" with an interval of 10 days were performed . "SUNEKOS® 200" was injected with two different techniques, carried out mono-laterally on the left or right face side randomly: "retrograde interstitial fluid technique" (RIFT) on one face side; bolus technique on five pre-determined face points (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) on the contralateral face side.
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 | Experimental | Normotypic or overweight subjects with rounded, oval or squared face (aged 35-50 years) Receives: Device: SUNEKOS ® 200 |
| GROUP 2 | Experimental | Thin subjects with oval or triangular face and "sagging" skin (aged 45-60 years) Receives: Device: "SUNEKOS® 1200" and "SUNEKOS® 200" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of wrinkles grade of the area around the eyes
Reduction of grade of the area around the eyes corresponding to a decrease from the baseline of the Glogau's reference photographic scale clinical score where:
Type 1 (No Wrinkles) Early photo-aging, mild pigment changes, minimal wrinkles, no 'age spots'; Type 2 (Wrinkles in Motion) Early to moderate photo-aging, appearance of lines only when face moves, early brown 'age spots', skin pores more prominent, early changes in skin texture; Type 3 (Wrinkles at Rest) Advanced photo-aging, prominent brown pigmentation, visible brown 'age spots', prominent and small blood vessels, wrinkles now present with face at rest; Type 4 (Only Wrinkles) Severe photoaging, wrinkles everywhere (at rest or moving) yellow-grey skin color, prior skin cancers, pre-cancerous skin changes (actinic keratosis).
Measured: Baseline (T0), immediately after the 1st "Sunekos® 200" injection treatment (T1i), 60 days (T60).
Variation of Wrinkle Severity Rating Scale (WSRS) grade
Reduction of wrinkles severity corresponding to a decrease from the baseline of the Wrinkle Severity Rating Scale (WSRS) clinical score where:
Grade 1 (absent): no visible nasolabial fold; continuous skin line. Grade 2 (mild): shallow but visible nasolabial fold with a slight indentation; minor facial feature.
Grade 3 (moderate): moderately deep nasolabial folds; clear facial feature visible at normal appearance but not when stretched.
Grade 4 (severe): very long and deep nasolabial folds; prominent facial feature; <2mm visible fold when stretched.
Grade 5 (very severe): extremely deep and long nasolabial fold, detrimental to facial appearance; 2-4 mm visible V-shaped fold when stretched.
Measured: Baseline (T0), immediately after the 1st "Sunekos® 200" injection treatment (T1i), 60 days (T60).
Variation of Facial Volume Loss Scale (FVLS) grade
Reduction of face volume loss corresponding to a decrease from the baseline of the Facial Volume Loss Scale (FVLS) where:
Grade 1 Mild flattening or shadowing of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). No prominent bony landmarks. No visibility of underlying musculature.
Grade 2 An intermediate point between grade 1 and grade 3. Grade 3 Moderate concavity of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas. Prominence of bony landmarks. May have visibility of underlying musculature.
Grade 4 An intermediate point between grade 3 and grade 5. Grade 5 Severe indentation of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). Severe prominence of bony landmarks. Clear visibility of underlying musculature
Measured: Baseline (T0), immediately after the 1st "Sunekos® 200" injection treatment (T1i), 60 days (T60).
Secondary outcomes (2)
Photographic documentation (3D pictures)
Three-dimensional pictures of the face taken by VECTRA H1 handheld imaging system
Measured: Baseline (T0), immediately after the 1st "Sunekos® 200" injection treatment (T1i), 60 days (T60).
Face volume variation
Face volume image analysis was carried on the 3D pictures taken by Vectra H1 thanks to Vectra analysis module (VAM) software
Measured: Baseline (T0), immediately after the 1st "Sunekos® 200" injection treatment (T1i), 60 days (T60).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start19 Oct 2017
- Primary completion21 Dec 2017
- Study completion21 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Face PhotoagingStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derming SRL
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adele Sparavigna, Derming SRL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425955
- Sponsor's protocol ID
- E1817
- Status last verified
- Feb 2018
- First submitted
- 2 Feb 2018
- Last updated
- 8 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aesthetic Performance of an Intradermal Injection Treatment for Face Photoaging: Interstitial or Cushion Technique in Comparison to Bolus Technique at Five Points (Half - Face Method Within Subjects)
- ClinicalTrials.gov ID
- NCT03425955
- Acronym / sponsor ID
- E1817
- Conditions
- Face Photoaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Derming SRLUniversity, hospital or other
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 8 Feb 2018 (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.
Aesthetic performance of "SUNEKOS® 200" injectable treatment on main sign of face skin aging in normotypic or overweight subjects with rounded, oval or squared face and in thin subjects with oval or triangular face and "sagging" skin.Interstitial or cushion technique in comparison to bolus technique at five points (half - face method within subjects).
Detailed description
Spontaneous, open, clinical trial, conducted by one centre under dermatological control. Primary end point of the study was to evaluate clinically and by non-invasive instrumental measurements the aesthetic performance of "SUNEKOS® 200" injectable treatment on main sign of face skin aging in normotypic or overweight subjects with rounded, oval or squared face and in thin subjects with oval or triangular face and "sagging" skin.
The micro-injections of the study product were executed by a specialized dermatologist, on the face of female volunteers with photoaging of mild/moderate grade; to improve the treatment aesthetic performance two different injection techniques were carried out mono-laterally on the left or right face side randomly: "interstitial fluid technique" (IFT) for the 1st subjects' typology (aged 35-50 years) and "cushion technique" in association to "retrograde interstitial fluid technique" (RIFT) for the 2nd (aged 45-60). On the contralateral face side the injection treatment was performed by bolus technique on five pre-determined face points, preceding for the 2nd subjects' typology by cushion technique.
It was also aim of this study to evaluate tolerance both by investigator and volunteers and efficacy by the volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 | Experimental | Device: SUNEKOS ® 200Normotypic or overweight subjects with rounded, oval or squared face (aged 35-50 years) |
| GROUP 2 | Experimental | Device: "SUNEKOS® 1200" and "SUNEKOS® 200"Thin subjects with oval or triangular face and "sagging" skin (aged 45-60 years) |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- female sex,
- age 35-50 years for the group 1 and 45-60 years for the group 2,
- mild/moderate cutaneous photoaging according to a reference photographic scale
- skin phototype I, II and III according to Fitzpatrick's classification, with a preference to grade II-III ,
- agreeing to present at each study visit without make-up,
Key exclusion criteria (25 listed)
- Pregnancy,
- lactation,
- subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study,
- subjects not in menopause who do not accept to perform the pregnancy test during the basal visit, 30 days (T4i) and 60 days (T60) after the first injection procedure,
- Body Mass Index (BMI) variation (± 1) during the study period,
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 |
|---|---|---|
| SUNEKOS ® 2004 micro-injection sessions of "SUNEKOS® 200" with an interval of 10 days. Two different injection techniques were carried out mono-laterally on the left or right face side randomly: "interstitial fluid technique" (IFT) on one face side; bolus technique on five pre-determined face points (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) on the contralateral face side. | Device | GROUP 1 |
| "SUNEKOS® 1200" and "SUNEKOS® 200"5 micro-injection sessions (one of the product "SUNEKOS® 1200" and four of "SUNEKOS® 200". "SUNEKOS® 1200" was injected bi-laterally on the face with cushion technique. 24 hours after the "SUNEKOS® 1200" treatment, 4 micro-injection sessions of "SUNEKOS® 200" with an interval of 10 days were performed . "SUNEKOS® 200" was injected with two different techniques, carried out mono-laterally on the left or right face side randomly: "retrograde interstitial fluid technique" (RIFT) on one face side; bolus technique on five pre-determined face points (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) on the contralateral face side. | Device | GROUP 2 |
Primary outcome
Variation of wrinkles grade of the area around the eyes
Time frame: Baseline (T0), immediately after the 1st "Sunekos® 200" injection treatment (T1i), 60 days (T60).
Reduction of grade of the area around the eyes corresponding to a decrease from the baseline of the Glogau's reference photographic scale clinical score where: Type 1 (No Wrinkles) Early photo-aging, mild pigment changes, minimal wrinkles, no 'age spots'; Type 2 (Wrinkles in Motion) Early to moderate photo-aging, appearance of lines only when face moves, early brown 'age spots', skin pores more prominent, early changes in skin texture; Type 3 (Wrinkles at Rest) Advanced photo-aging, prominent brown pigmentation, visible brown 'age spots', prominent and small blood vessels, wrinkles now present with face at rest; Type 4 (Only Wrinkles) Severe photoaging, wrinkles everywhere (at rest or moving) yellow-grey skin color, prior skin cancers, pre-cancerous skin changes (actinic keratosis).
Variation of Wrinkle Severity Rating Scale (WSRS) grade
Time frame: Baseline (T0), immediately after the 1st "Sunekos® 200" injection treatment (T1i), 60 days (T60).
Reduction of wrinkles severity corresponding to a decrease from the baseline of the Wrinkle Severity Rating Scale (WSRS) clinical score where: Grade 1 (absent): no visible nasolabial fold; continuous skin line. Grade 2 (mild): shallow but visible nasolabial fold with a slight indentation; minor facial feature. Grade 3 (moderate): moderately deep nasolabial folds; clear facial feature visible at normal appearance but not when stretched. Grade 4 (severe): very long and deep nasolabial folds; prominent facial feature; <2mm visible fold when stretched. Grade 5 (very severe): extremely deep and long nasolabial fold, detrimental to facial appearance; 2-4 mm visible V-shaped fold when stretched.
Variation of Facial Volume Loss Scale (FVLS) grade
Time frame: Baseline (T0), immediately after the 1st "Sunekos® 200" injection treatment (T1i), 60 days (T60).
Reduction of face volume loss corresponding to a decrease from the baseline of the Facial Volume Loss Scale (FVLS) where: Grade 1 Mild flattening or shadowing of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). No prominent bony landmarks. No visibility of underlying musculature. Grade 2 An intermediate point between grade 1 and grade 3. Grade 3 Moderate concavity of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas. Prominence of bony landmarks. May have visibility of underlying musculature. Grade 4 An intermediate point between grade 3 and grade 5. Grade 5 Severe indentation of one or more facial regions (including the cheek, temple, preauricolar and periorbital areas). Severe prominence of bony landmarks. Clear visibility of underlying musculature
2 secondary outcomes
Photographic documentation (3D pictures)
Time frame: Baseline (T0), immediately after the 1st "Sunekos® 200" injection treatment (T1i), 60 days (T60).
Face volume variation
Time frame: Baseline (T0), immediately after the 1st "Sunekos® 200" injection treatment (T1i), 60 days (T60).
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 8 Feb 2018.
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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 SUNEKOS ® 200 and "SUNEKOS® 1200" and "SUNEKOS® 200" in people with Face Photoaging, run by Derming SRL at 1 site in Italy.
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 8 inclusion and 25 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 8 Feb 2018. 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 Italy. 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?
Variation of wrinkles grade of the area around the eyes (time frame: Baseline (T0), immediately after the 1st "Sunekos® 200" injection treatment (T1i), 60 days (T60).). The study lists 3 primary outcomes in all. 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 8 Feb 2018.