WrinklesPhase 4E2912NCT01948531
Clinical Trial on a Topical "Antiage" Face Gel
A Phase 4 study testing Gynomunal® gel in people with Wrinkles, run by Derming SRL at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wrinkles
- What is being tested?
- Gynomunal® gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2012to Feb 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- change in the normal life habits during the month preceding the inclusion.
- 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
- pulmonary disease
- cancer
- neurological or psychological disease
- inflammatory/immunosuppressive disease
- drug allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Instrumental Evaluation of a Topical "Antiage" Formulation for the Face
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.
Read the detailed description
Controlled clinical trial that foresees the application of the study product for an uninterrupted period of 4 weeks. 4 visits will be performed: a basal visit (T0), a short term evaluation 20 minutes after the 1st product application (T20min) and a long term evaluation after 2 (T2 - intermediate visit) and 4 (T4 - final visit) week-treatment.
The study will be conducted on 33 healthy volunteers of female sex, 11 women for each of the following groups:
- 35-44 years
- 45-54 years
- 55-65 years The volunteers accept to respect the rules fixed in the list of recruitment criteria and not to deviate from their normal life habits. Moreover, the month preceding the inclusion visit and during the entire period of treatment, normal cleansing habits must be maintained, sun and UV light exposure, avoided. In the case of UV exposure must be used a sun screen total block cream.
Each volunteer is precisely informed about the study, a consent form being completed and signed. At the end of the study the investigator will declare to have informed all the volunteers participating it, signing and dating the relative form.
The study will be started only after Independent Ethical Committee approval. It is understood that the treatment would be immediately interrupted as soon as the investigator judges it necessary.
For each volunteer a Case Record Form is filled and to each one a progressive number is assigned. Personal data, subject's history, clinical and instrumental evaluations are registered in basal conditions and at all study visits.
During 3 hours before the visit the volunteer must not smoke, drink coffee or alcohol. Any cosmetic product can be used on the skin test area during 2 hours before the visit. All measurements are performed under standard environmental conditions (Temperature=22+\-2°C; Relative Humidity<60%).
Before each visit the volunteer will get acclimatized under relax conditions for at least 10-15 min.
Each volunteer will report on the personal diary card all information about the date, the time of study product application and a comment if necessary.
At each visit, the volunteers must give back the diary card to the Investigator to verify their compliance.
Samples are handled by DermIng in accordance with the methods described in the company operating procedures (SOP).
This trial is carried out by DermIng in accordance with the methods described in its own company operating procedures (SOPs). The information and data on the trial are generated, recorded, documented and processed in accordance with the methods described in the following procedure, based on ICH GCP 1996. The trial is covered by an insurance policy provided by Polichem S.A. to cover any damages related to the study product.
Statistical plan: the activity of the test product at T20min, T2 and T4 will be expressed in absolute values versus baseline (T0) for the entire population and for each evaluated group (35-44 yeas, 45-54 years, 55-65 years). Moreover a comparison between groups will be carried out at each considered time. Clinical data The statistical analysis of clinical data is carried out with not parametric test, while the analysis of all instrumental data are carried out with parametric test.
- Conditions
- Wrinkles
- Being tested
- Gynomunal® gel
- Keywords
- Antiage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gynomunal® gelDrug
Also called Ialuronic acid gel
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Gynomunal® gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks
Secondary outcomes (2)
Plastoelasticity
Among the various methods studied in order to measure the skin elasticity grade, the torsion one is the most effective, as it is very sensible to the variations of the mechanical properties of the corneum stratum. Skin firmness is measured with the instrument Dermal Torque Meter (Dia-Stron Ltd., UK). This instrument is based on the principle of the torsion given to the skin surface by a probe made of two circles that adhere to the skin through shaped adhesive tapes. The internal circle rotation, while the external circle is still, exerts a constant torsion of the skin (torsion time = 1 second with a torque = 9mN*m). The instrument measures the torsion angle (θ) during the mechanical stimulus ("torque on") and after it has ceased ("torque off").
Parameters:
Ue: immediate extensibility ("torque on" at 0.02 sec.) Uf: maximum extensibility ("torque on" at 0.9 sec.) Uv: viscoelasticity Ur: immediate elastic recovery ("torque off" at 0.02 sec.).
Measured: 4 weeks
Electrical capacitance of skin (hydration)
Hydration is measured by the instrument Corneometer CM825 (Courage - Khazaka, Köln, Germany): a square sensor (49mm2) frontally covered by a special glass, mounted on a spring cursor able to measure electrical capacity. Leaning the sensor on the skin surface, with a constant pressure thanks to the spring cursor it is possible to perform measures. The sensor acts as a capacitor. When a voltage is applied to this capacitor, the quantity of electric charge stored will be dependent on the dielectric properties of the material in contact with the probe. Water has an unusually high dielectric constant and so its presence in the skin is readily detectable by this method. So the measure of the skin capacitance properties is an indirect expression of its hydration level.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startDec 2012
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derming SRL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adele Sparavigna, Medical Doc, Principal investigator, Derming SRL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948531
- Sponsor's protocol ID
- DermIng E2912
- Acronym
- E2912
- Status last verified
- Sep 2013
- First submitted
- 10 Dec 2012
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Instrumental Evaluation of a Topical "Antiage" Formulation for the Face
- ClinicalTrials.gov ID
- NCT01948531
- Acronym / sponsor ID
- E2912 / DermIng E2912
- Conditions
- Wrinkles
- Keywords
- Antiage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Derming SRLUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 23 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Controlled clinical trial that foresees the application of the study product for an uninterrupted period of 4 weeks. 4 visits will be performed: a basal visit (T0), a short term evaluation 20 minutes after the 1st product application (T20min) and a long term evaluation after 2 (T2 - intermediate visit) and 4 (T4 - final visit) week-treatment.
The study will be conducted on 33 healthy volunteers of female sex, 11 women for each of the following groups:
- 35-44 years
- 45-54 years
- 55-65 years The volunteers accept to respect the rules fixed in the list of recruitment criteria and not to deviate from their normal life habits. Moreover, the month preceding the inclusion visit and during the entire period of treatment, normal cleansing habits must be maintained, sun and UV light exposure, avoided. In the case of UV exposure must be used a sun screen total block cream.
Each volunteer is precisely informed about the study, a consent form being completed and signed. At the end of the study the investigator will declare to have informed all the volunteers participating it, signing and dating the relative form.
The study will be started only after Independent Ethical Committee approval. It is understood that the treatment would be immediately interrupted as soon as the investigator judges it necessary.
For each volunteer a Case Record Form is filled and to each one a progressive number is assigned. Personal data, subject's history, clinical and instrumental evaluations are registered in basal conditions and at all study visits.
During 3 hours before the visit the volunteer must not smoke, drink coffee or alcohol. Any cosmetic product can be used on the skin test area during 2 hours before the visit. All measurements are performed under standard environmental conditions (Temperature=22+\-2°C; Relative Humidity<60%).
Before each visit the volunteer will get acclimatized under relax conditions for at least 10-15 min.
Each volunteer will report on the personal diary card all information about the date, the time of study product application and a comment if necessary.
At each visit, the volunteers must give back the diary card to the Investigator to verify their compliance.
Samples are handled by DermIng in accordance with the methods described in the company operating procedures (SOP).
This trial is carried out by DermIng in accordance with the methods described in its own company operating procedures (SOPs). The information and data on the trial are generated, recorded, documented and processed in accordance with the methods described in the following procedure, based on ICH GCP 1996. The trial is covered by an insurance policy provided by Polichem S.A. to cover any damages related to the study product.
Statistical plan: the activity of the test product at T20min, T2 and T4 will be expressed in absolute values versus baseline (T0) for the entire population and for each evaluated group (35-44 yeas, 45-54 years, 55-65 years). Moreover a comparison between groups will be carried out at each considered time. Clinical data The statistical analysis of clinical data is carried out with not parametric test, while the analysis of all instrumental data are carried out with parametric test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gynomunal® gel | Experimental | Drug: Gynomunal® gelThe 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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gynomunal® gelAlso: Ialuronic acid gelA 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). | Drug | Gynomunal® gel |
Primary outcome
Wrinkles profilometry (Ra - micrometers)
Time frame: 4 weeks
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).
2 secondary outcomes
Plastoelasticity
Time frame: 4 weeks
Electrical capacitance of skin (hydration)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adele Sparavigna, Medical Doc principal investigator
Derming SRL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gynomunal® gel in people with Wrinkles, run by Derming SRL at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wrinkles profilometry (Ra - micrometers) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2013.