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

NCT01221922 | Completed

• 1 other identifier: C67-10-A
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Acne Scars

Outcome Measures

Primary Outcomes (1)

• Global Acne Scarring Classification

  3 Months post final treatment

Secondary Outcomes (1)

• Subject Satisfaction

  3 Months post final treatment

Study Arms (1)

Acne treatment

EXPERIMENTAL

Treatment of acne scars

Device: RevLite Q-Switched Nd:YAG Laser

Interventions

RevLite Q-Switched Nd:YAG Laser DEVICE

Laser treatment once every 2 weeks for a total of 10 treatments.

Acne treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older with Fitzpatrick Skin Type III, IV, V or VI
• Evidence of atrophic scarring

You may not qualify if:

• 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

Sponsors & Collaborators

• ConBio, a Cynosure Company: lead

Study Sites (1)

Kasemrad Aesthetic Center, Kasemrad Prachacheun Hospital

Bangkok, Thailand

Location

Study Officials

• Niwat Polnikorn, MD

  Kasemrad Aesthetic Center, Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 18, 2010
• Study Start: October 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: November 28, 2012

Record last verified: 2012-11

Locations

TH (1)