Study for effects of Masport in adults

Phase 1

• Conditions: Glabellar Facial lines.

• Registration Number: IRCT201201154536N2
• Lead Sponsor: Masoondarou Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

male or females age between 18 to 60 years old with moderate to severe glabellar facial lines
Exclusion criteria: evidence of any unusual condition in volunteer, i.e.: severe allergic reactions, need for use of corticosteroids, evidence of pregnancy before administration of products and abnormal results of paraclinical tests (leukocytopenia , leukocytosis , thrombocytopenia , anemia , hyperkalemia , hypokalemia , hypernatremia , hyponatremia) .

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence any local and systemic adverse effects. Timepoint: At day 3, 7, 14, 30, 60, 90 and 120 post-injection. Method of measurement: Clinical examination , blood and urine analysis.;Subject Global Assessment of Change (SGA). Timepoint: At days 0 , 3 , 7 , 14 , 30 , 60 and 120 Post-injection. Method of measurement: Subject’s global assessment.;Rating of glabellar line severity at maximum frown. Timepoint: At days 3, 7, 14 and 30 post-injection. Method of measurement: Rating of glabellar line severity.

Secondary Outcome Measures

Name	Time	Method
Rating of glabellar line severity at rest. Timepoint: At day 30 post-injection. Method of measurement: Rating of glabellar line severity.