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

NCT03274232 | Completed

• 1 other identifier: DERMING E0916
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

Efficacy and tolerance evaluation of an intradermal injective treatment

Conditions

Face Skin Photoaging

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (6)

• Superficial skin hydration variation

  Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M)

• Deep skin hydration variation

  Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M)

• Skin plastoelasticity variation

  Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M)

• Variation of profilometric parameters

  Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M)

• Photographic documentation (3D pictures )

  Basal visit (T0), 2 months (T2M) , 3 months (T3M), 6 months (T6M)

Study Arms (1)

SUNEKOS ® 200

EXPERIMENTAL

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.

Device: SUNEKOS ® 200

Interventions

SUNEKOS ® 200 DEVICE

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

SUNEKOS ® 200

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Derming SRL: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 6, 2017
• Study Start: October 27, 2016
• Primary Completion: April 25, 2017
• Study Completion: April 25, 2017
• Last Updated: September 6, 2017

Record last verified: 2017-07