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

Derming

Status: Completed

Conditions: Face Skin Photoaging

Treatments: Device: SUNEKOS ® 200

Study type: Interventional

Funder types: Other

Identifiers

NCT03274232

DERMING E0916

Details and patient eligibility

About

Efficacy and tolerance evaluation of an intradermal injective treatment

Full 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.

Enrollment: 25 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

SUNEKOS ® 200

Experimental group

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.

Treatment:

Device: SUNEKOS ® 200