NCT00748462CompletedPhase 4
Clinical Quality Assurance Study: Fractional CO2 Treatment of Acne Scars in Asians
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Mahidol University
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- by the clinical investigator and graded into one of six categories: worse, no effect, slightly better, fair, good, and excellent. The results shall be reported.
Study Overview
Brief Summary
The objective of this study is to investigate the efficacy and side effects of a fractional CO2 laser for treatment of acne scar in Asians.
Detailed Description
- The objective of this study is to investigate the efficacy and side effects of a fractional CO2 laser for treatment of acne scar in Asians.
- Study hypothesis
- Reduction in acne scars based on blinded evaluation of before photos and the one and three month follow-up photos after four full face Ellipse Juvia with low density treatments with a fluency of 90-105 mJ/MTZ is statistically significant (5%).
- The direct clinical blinded evaluated reduction in acne scars based on before photos and the patient in life, by the one and three month follow-up is statistically significant (5%)
- Reduction in fine lines based on blinded evaluation of before photos and the one and three month follow-up photos after four full face Ellipse Juvia with low density treatments with a fluency of 90-105 mJ/MTZ is statistically significant (5%).
- The direct clinical blinded evaluated reduction in fine lines based on before photos and the patient in life, by the one and three month follow-up is statistically significant (5%).
- Reduction in pigmented disorders based on blinded evaluation of before photos and the one and three month follow-up photos after four full face Ellipse Juvia with low density treatments with a fluency of 90-105 mJ/MTZ is statistically significant (5%).
- The direct clinical blinded evaluated reduction in pigmented disorders based on before photos and the patient in life, by the one and three month follow-up is statistically significant (5%).
- Improvements in skin texture and pore size based on blinded evaluation of before photos and the one and three month follow-up photos after four full face Ellipse Juvia with low density treatments with a fluency of 90-105 mJ/MTZ is statistically significant (5%).
- The direct clinical blinded evaluated reduction in skin texture and pore size based on before photos and the patient in life, by the one and three month follow-up is statistically significant (5%).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Numbers of volunteers: 10 healthy men and women
- •Aged at least 30 year old
- •Skin type: 1 - 4
- •Degree of suntan: None - light
- •Skin condition: visible acne scars
Exclusion Criteria
- •Fitzpatrick skin types 5-
- •Patients with lesions with any clinical suspicion of being pre-cancerous or skin malignancies of any kind.
- •Patients with skin diseases associated with Koebner phenomena.
- •Patients who have used Botox or filler injection to the periorbital or perioral regions 12 months prior or during the study.
- •Patients who have used topical retinoids, AHA under prescription or Vitamin C, 3 months prior to or during the study.
- •Patients who are pregnant or who wish to become pregnant and lactating women.
- •Patients who have been exposed to sun within 2 week from date of treatment.
- •Patients prone to hypertrophic scars or keloids
- •Patients who have previously undergone laser resurfacing may not be suitable for yet another procedure.
- •Patients undergoing oral retinoid therapy for acne in the past 6 months.
- •Patients who suffer from any serious medical condition, including diabetes, bleeding diathesis, delayed wound healing or prednisolone intake.
- •Patients with wound infections (herpes, other) on the day of treatment.
- •Patients with moderate and severe inflammatory acne, Immunosuppressed patients, History of vitiligo.
- •Patients with unrealistic concerns/expectations and inability to do the appropriate post-operative care.
Arms & Interventions
1
Experimental
Fractional CO2 laser resurfacing
Intervention: Fractional CO2 Laser (Device)
Outcomes
Primary Outcomes
by the clinical investigator and graded into one of six categories: worse, no effect, slightly better, fair, good, and excellent. The results shall be reported.
Time Frame: Follow-up 1 and 3 months after the last treatment
Secondary Outcomes
- The outcome and degree of satisfaction based on the before photo is evaluated by the patients themselves(Follow-up 1 and 3 months after the last treatment)
Investigators
Woraphong Manuskiatti, M.D.
Professor
Mahidol University
Study Sites (1)
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