Face Photoaging: Efficacy and Tolerance Evaluation of an Intradermal Injective Treatment

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

SUNEKOS ® 200

About this trial

This is an interventional treatment trial for Face Skin Photoaging

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

- female sex;
age 45-65 years;
mild/moderate cutaneous photoaging according to a reference photographic scale (see Appendix 8)
skin phototype I, II and III according to Fitzpatrick's classification, with a preference to grade II-III (see par. 8.1)
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.

Exclusion Criteria:

Dependent on the volunteers' characteristics
Pregnancy;
lactation;
subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
Body Mass Index (BMI) variation (± 1) during the study period;
subjects not in menopause who do not accept to perform the pregnancy test during the basal visit, 30 days (T4i) and 2 months (T2M) after the first biomineralizing treatment execution;
performing skin treatments for aesthetic correction (biomaterials implants, face lifting, botox injections, laser, chemical peeling) in the 12 months prior to the study start;
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;
participation in a similar study actually or during the previous 6 months.
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);
assumption of drugs able to influence the test results in the investigator opinion.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SUNEKOS ® 200

Arm Description

The 1st intradermal treatment (T1i) was performed during the basal visit (T0), after basal evaluations planned by the study procedure and repeated after 10 (T2i), 20 (T3i) and 30 (T4i) days.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Superficial skin hydration variation

Improvement of skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany). The measure of the skin capacitance properties is an indirect expression of its hydration level.

Deep skin hydration variation

Improvement of tissue dielectric constant value of superficial and deep skin layers measured with MoistureMeterD (Delfin Technologies, Kuopio - Finland)

Skin plastoelasticity variation

Improvement of the principal torsiometric parameters Ue (immediate extensibility), Uf (final extensibility), Uv (viscoelasticity) and Ur (immediate elastic recovery).Skin firmness is measured with the instrument Dermal Torque Meter (Dia-Stron Ltd., UK).

Variation of profilometric parameters

Reduction of the crow's feet lines profilometric parameters versus baseline where Ra is average roughness of the analysed profile, Rt is wrinkles total high, Rv is wrinkles maximum depth.

Photographic documentation (3D pictures )

Three-dimensional pictures of the face taken by VECTRA H1 handheld imaging system.

Face volume variation

Face volume image analysis was carried on the 3D pictures taken by Vectra H1 thanks to Vectra analysis module (VAM) software

Full Information

NCT ID

NCT03274232

First Posted

August 31, 2017

Last Updated

September 1, 2017

Sponsor

Derming SRL

1. Study Identification

Unique Protocol Identification Number

NCT03274232

Brief Title

Face Photoaging: Efficacy and Tolerance Evaluation of an Intradermal Injective Treatment

Official Title

Efficacy and Tolerance of an Injectable Medical Device Containing Hyaluronic Acid and Amino Acids: a Monocentric Six-month Open-label Evaluation

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

October 27, 2016 (Actual)

Primary Completion Date

April 25, 2017 (Actual)

Study Completion Date

April 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Derming SRL

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

Efficacy and tolerance evaluation of an intradermal injective treatment

Detailed Description

Primary end point of the study was to evaluate clinically and by non-invasive instrumental evaluations tolerance and efficacy of SUNEKOS ® 200 injectable treatment on main sign of face skin photoaging; the micro-injections of the study product were performed by a specialized dermatologist, bilaterally on the face (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) of female volunteers aged 45-65 years, with photoaging of mild/moderate grade.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Face Skin Photoaging

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SUNEKOS ® 200

Arm Type

Experimental

Arm Description

The 1st intradermal treatment (T1i) was performed during the basal visit (T0), after basal evaluations planned by the study procedure and repeated after 10 (T2i), 20 (T3i) and 30 (T4i) days.

Intervention Type

Device

Intervention Name(s)

SUNEKOS ® 200

Intervention Description

micro-injections of the study product were performed by a specialized dermatologist, bilaterally on the face (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) of female volunteers aged 45-65 years, with photoaging of mild/moderate grade

Primary Outcome Measure Information:

Title

Variation of Wrinkle Severity Rating Scale (WSRS) grade

Description

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.

Time Frame

Basal visit (T0), 10 days(T2i), 20 days (T3i), 30 days (T4i), 2 months (T2M) , 3 months (T3M), 6 months (T6M)

Title

Variation of Facial Volume Loss Scale (FVLS) grade

Description

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.

Time Frame

Basal visit (T0), 10 days(T2i), 20 days (T3i), 30 days (T4i), 2 months (T2M) , 3 months (T3M), 6 months (T6M)

Secondary Outcome Measure Information:

Title

Superficial skin hydration variation

Description

Improvement of skin electrical capacitance value measured with Corneometer CM825 (Courage - Khazaka, Köln, Germany). The measure of the skin capacitance properties is an indirect expression of its hydration level.

Time Frame