Tolerance and Efficacy Evaluation of 3 Face Creams

NCT02063971 | Unknown DMC

• 1 other identifier: E3513 / SC13-235
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The study will evaluate the tolerance and the efficacy on skin comfort of F#1048-082 soothing cream used just after injection procedure and also the tolerance and the efficacy of the F#841-020 anti-age cream on aging parameters compared to baseline and to the F#1374-002 placebo cream (comparison within subjects - half face method) to identify additional benefits delivered by the product compared to a cosmetic procedure.

Conditions

Skin Aging

Keywords

Skin aging; Soothing activity; Hyaluronic acid injections

Outcome Measures

Primary Outcomes (1)

• Tolerance and the efficacy on skin comfort of F#1048-082 soothing cream used just after injection procedure on nasolabial folds

  For 7 days after injections (from T0 to T7d/T0'') the soothing cream will be applied twice a day on the full face and neck insisting on injection areas. 5 visits will be performed: a pre-test visit (T-30 subjects' screening), a baseline visit (T0 intradermal implant execution/ T0' evaluations just after the aesthetic procedure/ Timm evaluations immediately after the 1st soothing cream application), 2 intermediate visits (T1d, T3d - 1 and 3 days after injections) and a final visit (T7d - 7 days after the aesthetic procedure). Product tolerance (number of participants with adverse events) and efficacy: * clinical and self grading (performed on injection areas by VAS score) * optical colorimetry (on nasolabial folds - L\*a\*b\*) * photographic documentation (of all the face) will be performed at each study time.

  1 week

Secondary Outcomes (1)

• Evaluation of the tolerance and the efficacy of the F#841-020 anti-age cream on aging parameters compared to baseline and to the F#1374-002 placebo cream to identify additional benefits delivered by the product compared to a cosmetic procedure

  3 months

Study Arms (1)

Skin aging

EXPERIMENTAL

Anti-age product will be applied once a day, in the evening, on half face and neck for an uninterrupted period of 12 weeks and the placebo cream in the morning with the same modalities. On the contralateral face side (right or left side according to a previous randomisation list), the volunteers will apply the placebo cream twice a day

Other: Soothing (formulation number: F#1048-082) and antiaging creams (F#841-020 and F#1374-002)

Interventions

Soothing (formulation number: F#1048-082) and antiaging creams (F#841-020 and F#1374-002) OTHER

Skin aging

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female gender
• age \> 35 years old
• good general state of health
• woman who had already undergone Hyaluronic acid injections
• woman who have not applied any retinoid product in the last 3 months
• woman who are not in a recovery period after laser/peeling/acne treatment
• accepting to return to the centre for the planned visits
• accepting to follow the investigator's instructions during the entire study period
• agreeing to present at each study visit without make-up
• accepting to not change their habits regarding: food, physical activity, face cleansing and make-up use
• agreeing to not receive any drug able to change the skin characteristics during the entire duration of the study
• accepting to not receive any cutaneous anti-age treatment during the entire duration of the study
• 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:

• Pregnancy (only for subjects not in menopause)
• lactation (only for subjects not in menopause)
• 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 (T0), 6 and 12 weeks after the intradermal implant execution;
• subjects participating to a similar test less than 3 months ago
• sensitivity to the test products or theirs ingredients
• subjects whose insufficient adhesion to the study protocol is foreseeable.
• dermatitis
• presence of cutaneous disease on the tested area as lesions, scars, malformations.
• clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.)
• recurrent facial/labial herpes.
• diabetes
• endocrine disease
• hepatic disorder
• renal disorder

Sponsors & Collaborators

• Adele Sparavigna: lead

Study Sites (1)

DERMING

Monza, Monza-brianza, 20900, Italy

Location

Study Officials

• ADELE SPARAVIGNA, PHYSICIAN

  Derming SRL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 17, 2014
• Study Start: December 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 17, 2014

Record last verified: 2014-02

Locations

IT (1)