Klīnisks pētījums
Application of Retorna® cream (Catalysis S.L. Madrid) as an anti-aging preparation in women aged 35 to 60 years with ageing or damaged skin and Class I to III wrinkles
Head Researcher: Dr. Hana Zelenková, Ph.D., Svidník / SLOVAKIA, 2009
Conclusions of the study “Application of Retorna® cream (Catalysis S.L. Madrid) as an anti-aging preparation in women aged 35 to 60 years with ageing or damaged skin and Class I to III wrinkles”
Phase IV with post-registration monitoring randomised single blind controlled trial aimed to the following objectives: To verify the efficacy and tolerability of applying Retorna® cream, Catalysis Madrid in female trial participants with ageing or damaged skin on the face, neck and décolleté and assess the differences in the final effect and individual tolerability.
Number of Patients: 60 (4 Centres with 15 females each)
Number of applications: twice a day
Application duration: 3 months
Application information: given by the therapist both orally and in writing
Documentation: Work Protocol. Multi Skin Test Center® measurements
Basic laboratory screening: performed in every patient
Basic examination: Multi Skin Test Center® + Khazaka
Photodocumentation: pictures taken during every check-up to assess the c condition of single patients
Recommended daily hygiene: non irritating preparations with no influence on the therapy process
Inclusion criteria
- Aging or damaged skin on the face, neck and décolleté
- wrinkles of class I to III (see wrinkle classification system**)
- Outpatient status
- Age: 35 years and more
- Voluntary participation in the trial
- Written patient consent form confirmation
- One-time participation in the trial
Exclusion criteria - Specific exclusion criteria
- Known allergies to the tested preparation
- Disease focus infection manifestations (superinfection requiring therapy)
- Immunosuppressive therapy
- Cancer
- Malignancies
- Employment of other drug/s and /or preparation/s in therapy
Exclusion criteria - General exclusion criteria:
- Alcohol and drug abuse
- Painkiller abuse
- Participation in another clinical trial within the past 30 days
- Simultaneous participation in any other clinical trial
- Other reasons excluding the patient from the trial
- Restricted ability of the patient to follow therapy instructions
- Other physical or mental disorders disturbing the trial plan
- Possible consent withdrawal, presumed patient unreliability
CONCLUSIONS
- 13.33% women significant improvement in wrinkling, hydration, elasticity and sebum content
- 37.78% women moderate improvement in wrinkling, hydration, elasticity and sebum content
- 33.33% women insignificant improvement of the monitored parameters
- 13.33% women condition without visible improvement
- 2.22% women exclusion from the trial
Retorna ® cream by Catalysis S. L. Madrid represents a modern anti-aging preparation with positive influence on wrinkling. It helps achieve youthful with good cosmetic and aesthetic parameters.
The efficacy of Retorna® cream, Catalysis S. L. Madrid was verified in a pilot trial carried out in 2006 – 2007 and subsequently proven in many women in practice. The increased efficacy was achieved by molecular activation, increasing the activity of molecules 20 to 100 times. The composition of the preparation remained unchanged, only biological activity of the product was increased.
Following the application of Retorna® cream, Catalysis Madrid, P.L., the skin was smoother and slightly stretched. In the course of the first 4 weeks we observed reduction in fine wrinkles and in some women also improvement of inflammatory manifestations, for example in those patients suffering from acne menstruationis. The texture (as well as packing) Retorna® cream, Catalysis Madrid, P.L was appreciated by all women. Those women with dry skin would apply the cream three times a day, which is the application regimen some of them actually followed after trial termination.
The results of comparing the therapeutic effect of Retorna® cream, Catalysis S. L. Madrid and placebo in a group of 60 patients promote the usage Retorna® cream.
Adverse effects during the application including burning sensation, erythema, or pruritus were observed only in 1 patient applying placebo and 1 patient applying Retorna® cream, Catalysis S. L. Madrid: Excellent tolerability, practically no adverse effects and the possibility of applying the cream in women aged 30 to 35 years and high efficacy percentage in older women in preventing and reducing class II and III wrinkles are attributes which advocate wider usage of Retorna® cream Catalysis Madrid, S.L.
According to the results obtained, the application of Retorna® cream, Catalysis S. L. Madrid represents an efficient preventive dermatocosmetics modality. In order to potentiate the effect it is necessary to apply Retorna® cream two times a day for at least 3 months, protect the skin from UV rays or potentiate the effect by using systemic antioxidants.