Clinical Trial on a Topical "Antiage" Face Gel

NCT01948531 | Completed Phase 4 DMC

• 1 other identifier: DermIng E2912
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study is to evaluate clinically and by non-invasive instrumental evaluations the "antiage" activity of Gynomunal® gel after one single application on the face (short term evaluation) and 4 weeks of repeated use twice daily (long term evaluation) by healthy female volunteers. It is also aim of this study to evaluate cosmetic acceptability by the volunteers and efficacy and tolerance both by investigator and volunteers.

Conditions

Wrinkles

Keywords

Antiage

Outcome Measures

Primary Outcomes (1)

• Wrinkles profilometry (Ra - micrometers)

  A picture of crow's feet area is taken thanks to Primos compact portable device (GFMesstechnik); Primos software is able to elaborate 3D representations of skin wrinkles as well as to measure skin principal profilometric parameters in vivo or on skin replicas. As a measuring method Primos compact uses a digital stripe projection based on micro mirrors which allows for fast and highly precise measuring data acquisition (the speed of under 70ms for the measuring data admission provide perfect results of measurement).

  4 weeks

Secondary Outcomes (2)

• Plastoelasticity

  4 weeks

• Electrical capacitance of skin (hydration)

  4 weeks

Study Arms (1)

Gynomunal® gel

EXPERIMENTAL

The study will be conducted on 33 healthy volunteers of female sex aged between 35 and 65 years old; each subject will apply a fixed quantity of the Gynomunal gel on the face (including the submental area) twice a day, in the morning and in the evening (preferentially always at the same hour), with a mild massage.

Drug: Gynomunal® gel

Interventions

Gynomunal® gel DRUG

A fixed quantity of the cosmetic product will be applied on the face (including the submental area) twice a day, in the morning and in the evening (preferentially always at the same hour), with a mild massage according to the instructions received by the investigator during the basal visit (T0).

Also known as: Ialuronic acid gel

Gynomunal® gel

Eligibility Criteria

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

You may qualify if:

• female healthy subjects;
• age 35-65 years;
• presence of light-moderate face ritidosis;
• 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;
• 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;
• lactation;
• change in the normal habits regarding foods, physical activity, face cleansing and make-up use during the month preceding the test;
• sensitivity to the test product or its ingredients;
• subjects whose insufficient adhesion to the study protocol is foreseeable;
• participation in a similar study actually or during the previous 3 months;
• dermatitis;
• 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

Sponsors & Collaborators

• Derming SRL: lead

Study Sites (1)

DermIng S.r.l. Single Member Company

Monza, MB, 20900, Italy

Location

Study Officials

• Adele Sparavigna, Medical Doc

  Derming SRL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: September 23, 2013
• Study Start: December 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: September 23, 2013

Record last verified: 2013-09

Locations

IT (1)