A phase III, double-blind, placebo-controlled, randomized, three-arm parallel, study assessing efficacy and safety of 4 months of diosmin administration for the treatment of lower extremity teleangiectasias and gynoid lipodystrophy (edematous fibrosclerotic panniculopathy commonly known as cellulite)

Conditions: lower extremity teleangiectasias and gynoid lipodystrophy (edematous fibrosclerotic panniculopathy commonly known as cellulite)
MedDRA version: 17.0Level: LLTClassification code 10065339Term: CelluliteSystem Organ Class: 100000004858
MedDRA version: 17.0Level: LLTClassification code 10043193Term: TelangiectasisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2013-004539-57-PL

Lead Sponsor: ALIO MEDICA Sp. z o.o.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

1.Female subjects (aged = 18 to = 55 years), with body mass index (BMI) 18.50 – 34.99 kg/m2 (the minimum body weight - 50 kg).
2.Availability of the subject in maintaining a stable weight during the study (a variation of less than 8% from baseline body weight is permitted).
3.Having at least 2 separate areas measuring 3 cm x 3 cm of lower extremity telangiectasias as assessed by the Investigator at visit 1a.
4.Having lower extremity telangiectasias less than 1.0 mm in diameter, linear or branching, and red, pink, blue and/or purple in colour, as assessed by the Investigator at visit 1a.
5.Have a cellulite severity scale (CSS) score of = 4 representing mild to severe cellulite severity within the right buttock as assessed by the Investigator at visit 1a and the severity of the cellulite has an important psychological impact for the patient according to the patient..
6.Considering females of childbearing potential: subjects with negative urine pregnancy test at screening and who confirm using one of the effective contraception method: complete abstinence from sexual intercourses or barrier method with spermicide (condom, diaphragm) or intrauterine device (non-hormonal) since at least 4 weeks prior to the first study drug administration or hormonal contraception since at least 6 months prior to the first study drug administration and is willing to use it until completion of the examination at the end of the study.
7.Be willing to refrain from using any other procedure for the treatment of lower extremity spider veins and/or anti-cellulite treatment from screening and throughout the duration of the study.
8.Be willing to maintain habitual diet throughout the trial.
9.Be willing to refrain from making any significant lifestyle changes during the study (exercise regimens, specific diets).
10.Medical history which based on the investigator’s opinion, do not prevent the patient from taking part in the study and use the medicinal product under investigation.
11.Patient understands the study procedures and provides Informed Consent Form signed and dated prior to screening evaluations.
12.Regular menstrual cycle (cycles can range from 21 to 35 days).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Known allergy or hypersensitivity to diosmin or its derivatives and/or to any study product excipients.
2.Any other prior anti-cellulite treatment or body measures treatment or spider veins treatment, 30 days prior to the study (visit 1b).
3.Any prior aesthetic surgery affecting the area to be tested (e.g. liposuction), 3 months before the study (visit 1b), that may interfere with results.
4.Subjects with inflammation or active infection in the area to be tested.
5.Vascular disorder (e.g. phlebitis or varicose veins).
6.Lipoedema or a lymphatic disorder.
7.Coagulation disorders, using anticoagulants or tendency of bruises.
8.History of lower extremity thrombosis or post-thrombosis syndrome.
9.Documented autoimmune disorder such as lupus erythematosus, rheumatoid arthritis.
10.Cardiac insufficiency, asthma or bronchitis.
11.Hypertension.
12.Cutaneous alteration in area to be tested.
13.Subjects with diabetes mellitus any type.
14.Any known significant current or past acute or chronic disease or condition of the: circulatory system, respiratory system, hematopoietic system, alimentary tract, urinary tract, endocrine system, nervous system, musculoskeletal system that may influence the study in the Investigator opinion.
15.Current disease of the alimentary tract, liver or kidneys that may influence the study in the Investigator opinion.
16.Participation in another clinical research study within a period of 30 days prior to randomisation.
17.Abnormal baseline findings, including clinical laboratory results assessed by the Investigator as clinically relevant (CR).
18.Subjects who adhere to a special diet such as low calories (below 1000 kcal).
19.Subjects intensively tanned, or intending to expose the area of study to sun, artificial UV, or self-tanning during the study.
20.Subjects chronically using medication that might lead to disturbance of fluid balance and/or blood circulation (e.g. diuretics, steroids, antidepressants, nonsteroidal anti-inflammatory drugs) and may influence the study in the Investigator opinion.
21.Subjects using hormonal contraception for less than six months.
22.Subjects who smoke.
23.Pregnant, breast-feeding females.
24.Drug and/or alcohol dependence or abuse (use of > 2 units of alcohol a day).
25.Any reason the subject is considered by the Investigator to be an unsuitable candidate to participate in the study