Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Henry Ford Health System.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Henry Ford Health System
Information provided by:
Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT00641420
First received: March 17, 2008
Last updated: March 21, 2008
Last verified: March 2008
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Purpose
Fractionated laser resurfacing is commonly used as a treatment for acne scarring in fair skinned individuals. This study aims to test the efficacy and safety in darker skin types. Patients are randomized to either the 10mJ 40mJ dosages and receive a total of five treatments at 17% one month apart. Improvement is judged by a dermatologist as 0-25%, 25-50%, 50-75% or 75-100%. Side effects such as pigmentary abnormalities and pain are also evaluated.
| Condition | Intervention |
|---|---|
|
Acne Scarring |
Procedure: Fractionated Laser Resurfacing |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin |
Resource links provided by NLM:
Further study details as provided by Henry Ford Health System:
Primary Outcome Measures:
- Improvement in acne scarring. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Dyspigmentation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Pain with treatment [ Time Frame: 5 months ] [ Designated as safety issue: No ]
| Enrollment: | 15 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | September 2008 |
| Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 10mJ.
|
Procedure: Fractionated Laser Resurfacing
Other Name: Fractionated Laser: FRAXEL
|
|
Experimental: 2
Patients receive fractional laser resurfacing to 17% of the face five times one month apart at 40mJ.
|
Procedure: Fractionated Laser Resurfacing
Other Name: Fractionated Laser: FRAXEL
|
Eligibility| Ages Eligible for Study: | 18 Years to 59 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Male or female voluntary patients between the ages of 18 and 59 with Fitzpatrick skin type IV-VI as verified by one of the investigators
- Patients with clinical diagnosis of ice pick, rolling, or boxcar type ane scarring
- Patients able to follow instructions
- If patient has a history of cold sores (herpes labialis) they must be willing to take prophylactic valtrex
- Written informed consent from the patients (Appendix II)
Exclusion Criteria:
- Children (less than 18 years old)
- Pregnant or lactating women
- Personal history of keloids or hypertrophic scarring
- Active acne requiring topical or oral therapy
- Accutane or other oral retinoid in past year
- Patients with a known allergy to lidocaine
- Allergy to valacyclovir in a patient that needs prophylaxis
- Patients with an unstable or non controlled underlying medical problem
- Patients who are not able to follow instructions
- Patients who have participated in a study within the 3 months prior to study entry
- Patients who refuse to give written informed consent
- Patients with a history of a pigmentary abnormality
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641420
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641420
Locations
| United States, Michigan | |
| Henry Ford Health System | |
| Detroit, Michigan, United States, 48202 | |
Sponsors and Collaborators
Henry Ford Health System
Investigators
| Principal Investigator: | David M Ozog, MD | Henry Ford Health System |
More Information
| Responsible Party: | David Ozog, MD/ Director Cosmetic Dermatology, Henry Ford Health System |
| ClinicalTrials.gov Identifier: | NCT00641420 History of Changes |
| Other Study ID Numbers: | HenryFord4447 |
| Study First Received: | March 17, 2008 |
| Last Updated: | March 21, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Henry Ford Health System:
|
Acne scarring Post inflammatory hyperpigmentation |
Additional relevant MeSH terms:
|
Cicatrix Fibrosis Pathologic Processes |
ClinicalTrials.gov processed this record on September 23, 2016