Status:
COMPLETED
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)
Lead Sponsor:
Derming SRL
Conditions:
Face Photoaging
Eligibility:
FEMALE
35-60 years
Phase:
NA
Brief 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 t...
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 aes...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
October 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03425955
Start Date
October 19 2017
End Date
December 21 2017
Last Update
February 8 2018
Active Locations (1)
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1
DERMING
Milan, MI, Italy, 20149