IRCT20101012004920N11
Not yet recruiting
Phase 3
Comparison the efficacy and safety of botulinum toxin type A of Plasma Darman Sarve Sepid Company with Dysport® of Ipsen Co. in the treatment of the moderate to severe glabellar lines: a randomized, active controlled, double-blind, non-inferiority phase 3 trial
Plasma Darman Sarve Sepid Company0 sites202 target enrollmentTBD
ConditionsGlabellar lines.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Glabellar lines.
- Sponsor
- Plasma Darman Sarve Sepid Company
- Enrollment
- 202
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Both genders
- •Age between 25\- 55 years old
- •General health condition by medical history and physical examination
- •Moderate to severe Glabellar lines by GLS and GLSS criteria
- •Informed consent to participate in the study
Exclusion Criteria
- •Conditions that alter the safety results, like: eyelid ptosis or eyebrow ptosis; facial nerve paralysis; notable face asymmetry; overt dermatochalasis; deep dermal scar; thick sebaceous skin
- •Neuromuscular junction diseases i.e. Myasthenia Gravis; Eaton Lembert syndrome; Amyotrophic Lateral Sclerosis or other disease that alter neuromuscular function
- •Sever muscular atrophy or weakness in injection site
- •Previous injection of Botulinum neurotoxin in last 6 months
- •Participation in other trials related to Botulinum neurotoxin and fillers
- •History for hypersensitivity reaction to filler or gel injection or laser therapy in face area
- •History for Filler or gel injection in face
- •History for face plastic surgery i.e. tissue augmentation, eyebrow lifting or dermal resurfacing
- •History for cosmetic surgery (chemical peeling, laser) using materials that cause skin remodeling or active changes in forehead and near area (in 6 months).
- •History for eyebrow tattoo or other procedure in last month
Outcomes
Primary Outcomes
Not specified
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