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

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Cynosure

Status

Completed

Conditions

Acne Scars

Treatments

Device: RevLite Q-Switched Nd:YAG Laser

Study type

Interventional

Funder types

Industry

Identifiers

NCT01221922
C67-10-A

Details and patient eligibility

About

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).

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Acne treatment
Experimental group
Description:
Treatment of acne scars
Treatment:
Device: RevLite Q-Switched Nd:YAG Laser

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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