Retorna Facial Cream in the Treatment of Facial Wrinkles

Catalysis SL

Status and phase: Completed; Phase 3

Conditions: Facial Wrinkles

Treatments: Other: Placebo; Other: Retorna

Study type: Interventional

Funder types: Industry

Identifiers

NCT00978887

CAT-0906-CU

Details and patient eligibility

About

The purpose of the study is to assess the efficacy of Retorna facial cream usage in the reduction or total correction of facial wrinkles. The duration of this double-blind placebo controlled phase 3 clinical trial will be 4 weeks. The estimated number of women to be recruited and randomized for the study is 148. Occurrence of adverse effects will also be evaluated.

Enrollment: 148 estimated patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Facial wrinkles
• Signed informed consent
• Given verbal agreement on solar exposure prevention within hours of intense solar radiation (10 am - 4 pm) by the usage of physical protection methods such as umbrellas, caps and hats.

Exclusion criteria

• Pregnancy
• Breast-feeding
• Use of steroids within 6 months.
• Patients under other experimental treatment
• Decompensated concomitant diseases
• Malignant neoplastic conditions.
• Alcoholism
• Handicap and/or psychiatric condition preventing treatment accomplishment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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148 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Retorna (facial cream)

Treatment:

Other: Retorna

B

Placebo Comparator group

Description:

Placebo (facial cream)

Treatment:

Other: Placebo