| July 1, 2008 |
| September 5, 2008 |
| July 2008 |
| December 2008 (final data collection date for primary outcome measure) |
| 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 ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00748462 on ClinicalTrials.gov Archive Site |
| The outcome and degree of satisfaction based on the before photo is evaluated by the patients themselves [ Time Frame: Follow-up 1 and 3 months after the last treatment ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Fractional CO2 Treatment of Acne Scars in Asians |
| Clinical Quality Assurance Study: Fractional CO2 Treatment of Acne Scars in Asians |
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. |
- 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%).
|
| Phase IV |
| Interventional |
| Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Acne Scar, Wrinkle |
| Device: Fractional CO2 Laser |
| Experimental: Fractional CO2 laser resurfacing |
|
|
| |
| Recruiting |
| 12 |
| December 2008 |
| December 2008 (final data collection date for primary outcome measure) |
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 5-6.
- 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.
|
| Both |
| 25 Years to 75 Years |
| Yes |
|
|
| Thailand |
| |
| NCT00748462 |
| Ellipse A/S, Factulty of Medicine Siriraj Hospital, Mahidol University |
| SiEC 145/2551 (EC4), 1CIP7978- A02 |
| Mahidol University |
|
| Principal Investigator: |
Woraphong Manuskiatti, M.D. |
Department of Dermatology, Siriraj Hospital |
|
|
| Mahidol University |
| September 2008 |