Laser Treatment of Acne Scars in Fitzpatrick Skin Types III-VI

Acne Scars Clinical Trial

Official title:

A Study of the RevLite Q-Switched Neodymium: Yttrium-Aluminum-Garnet (Nd:YAG) Laser for the Treatment of Acne Scars in Fitzpatrick Skin Types III-VI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01221922
• Other study ID #: C67-10-A
• Status: Completed
• Phase: N/A
• First received: October 14, 2010
• Last updated: November 27, 2012
• Start date: October 2010
• Est. completion date: January 2012

Study information

• Verified date: November 2012
• Source: Cynosure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the RevLite Q-Switched Neodymium: Yttrium-Aluminum-Garnet (Nd:YAG) Laser in the treatment of acne scars in darker skin types (Fitzpatrick Skin Types III, IV, V and VI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older with Fitzpatrick Skin Type III, IV, V or VI

• Evidence of atrophic scarring

Exclusion Criteria:

• Pregnancy, lactating or planning to become pregnant during the study

• History of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis

• Any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy

• Any condition which, in the investigator's opinion, would make it unsafe for the subject to participate

• Currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days prior to entering the study

• Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function

• Subject may be unreliable for the study. This includes subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits

• Use of oral or topical isotretinoin therapy within 6 months prior to enrollment. With the exception of isotretinoin, subjects will be allowed to continue their topical or oral acne medications during the trial

• Need to be exposed to artificial tanning devices or excessive sunlight during the trial

• Prior treatment with parenteral gold therapy

• Diabetes Type I or II, Lupus, Scleroderma or a similar immune system disorder

• Subject does not agree to refrain from any other type of facial skin resurfacing (e.g., microdermabrasion, laser or IPL treatment, chemical peel) or injected filler/other substances (e.g., Restylane, Botox) that might affect the treatment area for the duration of the study

• Underlying silicone or other nonabsorbable fillers in the treatment area or has had filler (e.g., collagen, fat) injections within the past 3 months

• History of keloidal scarring or nodulocystic acne

• Phenol or chemical peel or dermabrasion to the the treatment area within the past 6 months

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Scars

Intervention

Device:
• RevLite Q-Switched Nd:YAG Laser
Laser treatment once every 2 weeks for a total of 10 treatments.

Locations

Country	Name	City	State
Thailand	Kasemrad Aesthetic Center, Kasemrad Prachacheun Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
ConBio, a Cynosure Company

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Acne Scarring Classification		3 Months post final treatment	No
Secondary	Subject Satisfaction	5 point Likert scale	3 Months post final treatment	No