THE EFFICACY AND SAFETY OF EPIDERMAL GROWTH FACTOR COMBINED WITH FRACTIONAL CARBON DIOXIDE LASER FOR ACNE SCAR TREATMENT: A SPLIT-FACE TRIA

Phase 2

Active, not recruiting

• Conditions: Atrophic acne scar

• Registration Number: TCTR20201111003
• Lead Sponsor: Thammasat University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-11
• Study Completion: 2021-01-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

1. Healthy males and females between 18 to 50 years old.
2. Fitzpatrick skin Types III to V
3. Patients who have Goodman and Baron grading II-IV atrophic acne
scars

Exclusion Criteria

1. Pregnant or lactating woman.
2. Patients who have a history of keloid or hypertrophic scar formation.
3. Patients who have active facial acne or any active facial inflammation.
4. Patients who had been taking oral isotretinoin within the preceding 6
months.
5. Patients who had been taking ablative laser within the preceding 6
months.
6. Patients who had been taking nonablative laser within the preceding
3 months.
7. Patients who have diabetes mellitus.
8. Patients who have collagen vascular disease.
9. Patients who have history of skin cancer.
10. Patients who have history of herpes labialis.
11. Patients who have allergic history to topical EGF or ingredients of
placebo.
12. Patients who have allergic history to topical anesthetic cream.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
scar improvement using Quartile grading scale At 1 month and 3 months after the final treatment session by two blinded dermatologists

Secondary Outcome Measures

Name	Time	Method
scar improvement by Antera 3D® camera At 1 month and 3 months after the final treatment session Antera 3D® skin analysis camera system, Post-procedure wound healing response assess daily for 7 days after the treatment session Erythema grading and scab shedding by physical investigator,Side effect evaluation (Erythema, edema and other side effects including petechiae, oozing, crustin) At Day 7, month 1, month 2, month 3 and month 5 physical investigator , Antera 3D®,Patient’s satisfaction evaluation At month 1, month 2, month 3 and month 5 Visual analogue scale (0-10)