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Completed

NCT Number: NCT01221922

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

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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasemrad Aesthetic Center, Kasemrad Prachacheun Hospital

Bangkok, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RevLite Q-Switched Nd:YAG Laser

Device

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

Primary outcomes

  1. Global Acne Scarring Classification

    Time frame: 3 Months post final treatment

Secondary outcomes

  1. Subject Satisfaction

    Time frame: 3 Months post final treatment

    5 point Likert scale

Sponsors and collaborators

Lead sponsor

ConBio, a Cynosure Company

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 18, 2010
Registry last updated
Nov 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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