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NCT06946160
A Non-inferiority Clinical Trial to Compare Efficacy and Safety of Abobotulinumtoxin A (Espad Pharmed) Versus AbobotulinumtoxinA (Dysport®, Ipsen Co.) for Correction of Moderate to Severe Glabellar Lines
Phase 3 trial testing Abobotulinumtoxin A (Espad Pharmed Darou Co.) in Glabellar Lines in 146 participants. Completed in 18 February 2025.
18 February 2025
Quick facts
| Lead sponsor | Espad Pharmed |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 146 |
| Start date | 28 May 2024 |
| Primary completion | 18 February 2025 |
| Estimated completion | 18 February 2025 |
| Sites | 1 location across Iran |
Drugs / interventions tested
- Abobotulinumtoxin A (Espad Pharmed Darou Co.) — full drug profile →
- Abobotulinumtoxin A (Ipsen Co.) — full drug profile →
Conditions studied
- Glabellar Lines — all drugs for Glabellar Lines →
- Glabellar Frown Lines — all drugs for Glabellar Frown Lines →
Sponsor
Espad Pharmed — full company profile →
Who can join
Adults 18 to 65, any sex, with Glabellar Lines or Glabellar Frown Lines. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study is to evaluate the efficacy and safety of AbobotulinumtoxinA (produced by Espad Pharmed Darou Co.) for correction of moderate to severe glabellar lines. Hypothesis: AbobotulinumtoxinA (produced by Espad Pharmed Darou Co.) has acceptable efficacy and safety profile for correction of moderate to severe glabellar lines. Primary Outcome: To verify the non-inferiority of the efficacy of AbobotulinumtoxinA (produced by Espad Pharmed Darou Co.) compared with AbobotulinumtoxinA (Dysport®, produced by Ipsen Co.) by percentage of responders at maximum frown at day 30 after treatment. Researchers will compare the efficacy and safety profile of AbobotulinumtoxinA (produced by Espad Pharmed Darou Co.) with AbobotulinumtoxinA (Dysport®, produced by Ipsen Co.). The study is designed as phase III, randomized, two armed, double-blind, parallel, active controlled, non-inferiority clinical trial. Participants received a total dose of 40-60 units into 3 to 5 sites. After two weeks, a touch-up intervention could be done based on physician's assessment.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06946160
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Glabellar Lines
Currently open trials in the same condition.
- NCT06205797 — To Evaluate HU-045 in the Treatment of Glabellar Lines(Phase III) · Phase 3 · recruiting
Other Espad Pharmed trials
Trials by the same sponsor.
- NCT07126912 — Evaluation of Efficacy and Safety of Alcarisa (Hyaluronic Acid Produced by Espad Pharmed Co.) for Restoration of Mid-fac · NA · recruiting
- NCT07004010 — Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) for the Treatment of Fla · NA · completed
- NCT06844760 — Evaluation of Effectiveness and Safety of Stabilized Injectable Hyaluronic Acid (Perleux Body, Produced by Espad Pharmed · NA · completed
- NCT07014163 — Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) Injection in the Managem · NA · recruiting
- NCT07102537 — Evaluation of Efficacy and Safety of Intella Dermal Filler in Moderate to Severe Nasolabial Folds · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06946160 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Espad Pharmed
- Last refreshed: 7 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06946160.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing