Acne Scar, Wrinkle Clinical Trial
— CO2Official title:
Clinical Quality Assurance Study: Fractional CO2 Treatment of Acne Scars in Asians
| Verified date | January 2014 |
| Source | Mahidol University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Thailand: Ethical Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | December 2008 |
| Est. primary completion date | December 2008 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 25 Years to 75 Years |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| Mahidol University |
Thailand,
Alster TS, Lupton JR. Erbium:YAG cutaneous laser resurfacing. Dermatol Clin. 2001 Jul;19(3):453-66. Review. — View Citation
Fitzpatrick RE, Goldman MP, Satur NM, Tope WD. Pulsed carbon dioxide laser resurfacing of photo-aged facial skin. Arch Dermatol. 1996 Apr;132(4):395-402. — View Citation
Fitzpatrick RE. Laser resurfacing today and the "cookbook" approach: a recipe for disaster? A comment. J Cosmet Dermatol. 2005 Dec;4(4):298-9; author reply 299-300. — View Citation
Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Follow-up 1 and 3 months after the last treatment | Yes | |
| Secondary | 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 | Yes |