A phase III, randomized, two armed, double-blinded, parallel, active-controlled, non-inferiority clinical trial to compare efficacy and safety of Santiage(Nano Darou Pajuhan Pardis) versus Dysprot®(Ispen Co.) for correction of moderate to severe glabellar line

Clinical trial to compare efficacy and safety of Santiage(Nano Darou Pajuhan Pardis) versus Dysprot®(Ispen Co.) for correction of moderate to severe glabellar line

Two arm parallel group randomized double blind active controlled trial with 168 participants. Random Chain Generation performed using by R-CRAN version 3.2.3. We used randomized permutations, blocks (the size of each block is 4) for a total of 168 volunteers (1: 1 ratio).

This clinical study is conducted on volunteers at the Center for research and training in skin diseases and leprosy. Before the intervention skin photograph will be taken for full face and frown lines, as well as urine lab test for the participants, then according to randomization code, the subjects will be treated with the relative drug (test or control). 14, 30, 60, 90 and 120 days later the skin photography will be repeated

Inclusion criteria: Men and women 18 to 65 years with moderate-to-severe glabellar lines at maximum frown Exclusion criteria:Allergies to botulinum toxin or any other compound in the formulation, Previous treatment with botulinum toxin within the last 6 months, History of filler injection in glabellar area during the last year

Intervention group: botulinum toxin type A Santiage(500iu vial produced by Nano Darou Pajuhan Pardis), intra muscular injection, 40-60iu in 3 point in frontal area in one visit

Percentage of subjects with improvement in Glabellar Lines at maximum frown

The reason for the update is changing in brand name (Nano Darou Pajuhan Pardis). Citing letter number 665/95126 dated 2025 January 2, the change of the brand name of Elletox to Santiage has been approved by the Food and Drug Administration of Iran.

Random Chain Generation performed using by R-CRAN version 3.2.3. We used randomized permutations, blocks (the size of each block is 4) for a total of 168 volunteers (1: 1 ratio). The codes will be labeled on the drugs. After ensuring the volunteer's eligibility and signing the informed consent form, a nurse will receive a code from the study site which will be used for random allocation of the drug to the candidate. The related drug will be injected for the volunteer. In this way, the volunteers fall into one of the two intervention groups and the volunteers' group and the type of drug they receive will not be disclosed to researchers or the study team.

All volunteers will be examined by a specialist physician at the site of the study and the injection will be done at 3 points of the face muscles after examining eligibility for entry. Due to availability of the drug in the study site and sticking the research label on the medications and injections by the doctor, volunteer and the doctor will not be aware of the type of drug. The ICF has also met the purpose of the study and the volunteer knows that it will be randomly assigned to one of the two treatment groups.