The Efficacy and Safety of Incobotulinumtoxin A for Jawline Acne, A Split-Face, Randomized Study

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20251231002

Enrollment

Registered

2025-12-31

Start date

2024-09-05

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Acne Sebum production Botulinum toxin Incobotulinumtoxin type A

Interventions

Jawline acne was treated with topical BP/ADP combined with intradermal incoBoNT/A. IncoBoNT/A was administered for 24 units as a single treatment during the baseline visit with topical anesthetic befo

Experimental Procedure/Surgery,Active Comparator Drug

Intradermal incoBoNT/A and BP/ADP,BP/ADP monotherapy

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: (i) Older than 18 years old (ii) Mild to moderate jawline acne, as defined by the Investigator Global Assessment (IGA)

Exclusion criteria

Exclusion criteria: (i) use of oral retinoids within the previous 6 months (ii) known allergy to botulinum toxin (iii) history of anesthetic hypersensitivity (iv) presence of skin infection or untreated inflammatory lesions in the jawline area (v) open wounds within the treatment zone (vi) active dermatologic conditions requiring treatment (vii) personal history of skin cancer (viii) history of keloid formation (ix) current use of antiplatelet or anticoagulant medications (x) pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Pore volume Baseline, 1, 2, 3, and 4 months post treatment Antera 3D imaging (mm3),Sebum production Baseline, 1, 2, 3, and 4 months post treatment Sebumeter,Acne lesion counts Baseline, 1, 2, 3, and 4 months post treatment Subjective evaluation by a blinded physician,Investigator Global Assessment (IGA) Baseline, 1, 2, 3, and 4 months post treatment Subjective evaluation by a blinded physician,Patient satisfaction 4 months post treatment Visual analogue scale,Pain score During the incobotulinumtoxin A injection at baseline Visual analogue scale	—

Measure

Time frame

Pore volume Baseline, 1, 2, 3, and 4 months post treatment Antera 3D imaging (mm3),Sebum production Baseline, 1, 2, 3, and 4 months post treatment Sebumeter,Acne lesion counts Baseline, 1, 2, 3, and 4 months post treatment Subjective evaluation by a blinded physician,Investigator Global Assessment (IGA) Baseline, 1, 2, 3, and 4 months post treatment Subjective evaluation by a blinded physician,Patient satisfaction 4 months post treatment Visual analogue scale,Pain score During the incobotulinumtoxin A injection at baseline Visual analogue scale

—

Secondary

Measure	Time frame
Adverse events Throughout the study Subjective evaluation by patients	—

Countries

Thailand

Contacts

Public ContactVasanop Vachiramon

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

vasanop@gmail.com022011211

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026