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Evaluating the efficacy of Botox and fractional CO2 laser on preventing fresh facial scar formation

Evaluating the efficacy of Botulinum toxin type A and fractional CO2 laser on improving fresh facial surgical scars (Experimental, Histologic, and Randomized controlled trial. Split-Scar)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241002006
Enrollment
24
Registered
2024-10-02
Start date
2024-07-01
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

fresh facial scars. Hypertrophic scars.

Interventions

the study is a Split Scar design. in which each scar in every patient will be divided into 2 halves, the first half of all patients will receive the Botulinum toxin type A and fractional CO2 laser. t
s length. the botulinum toxin will be administered once. after 2 weeks, a session of fractional CO2 laser will be applied. the dose of fractional CO2 will range between 18 and 20 gol and maybe repeat
s length. the botulinum toxin will be administered once. ,The other half of the scar in some patients will receive fractional CO2 laser only. after 3 weeks following surgery, a session of fractional C
Active Comparator Other,Active Comparator Drug,Active Comparator Radiation,No Intervention No treatment
Botulinum toxin type A and fractional CO2 laser,Botulinum toxin type A alone.,fractional CO2 laser alone,control

Sponsors

Damascus University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1 Subject in good health, or with stable treated medical condition, as determined by the investigator. 2 Scheduled to undergo, or recently undergone facial surgery for fracture reduction, or removal of benign tumors, or had fresh facial cutting wounds. 3 wound closure size at least 4 cm in length 4 Willing and able to complete and comply with procedures, protocol requirements, and instructions, including completing all required visits. 5 Willing and able to sign and date the approved informed consent. 6 Able to speak, read, and understand the language of the informed consent form, and study questionnaires.

Exclusion criteria

Exclusion criteria: 1 Pregnant or breastfeeding, or planning a pregnancy. 2 Reported use of any botulinum toxin of any serotype within the last 6 months. 3 Known hypersensitivity to any botulinum toxin serotype. 4 Aminoglycoside intake within 48 hours before or during surgery. 5 Pre-existing neuromuscular junction disorders (myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral Sclerosis). 6 Any uncontrolled medical condition that in the opinion of the investigator could put the subject at undue safety risk.

Design outcomes

Primary

MeasureTime frame
Scar Appearance at time of intervention, one month, 3 months, and 6 months Visual Analogue Scale; Values From 0 (Worst) to 10 (Best)

Secondary

MeasureTime frame
Patient and observer scar assessment scale at time of intervention, one month, 3 months, and 6 months values from 0 to 10 for pain, itching, color, texture, thickness, regularity, vascularity, pigmentation, and elasticity.

Countries

Syrian Arab Republic

Contacts

Public ContactGamil ALMadhagy

Damascus University in syia

jimefara@gmail.com930664586

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026