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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01221922
Other study ID # C67-10-A
Secondary ID
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


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
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Completed NCT01213199 - Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars Phase 2
Completed NCT03380845 - Comparison of 1,550-nm Laser and Fractional Radiofrequency Microneedle for the Treatment of Acne Scars in Ethnic Skin N/A
Active, not recruiting NCT03901417 - Comparison of 1550nm Fractional Laser Alone Versus in Combination With Microneedling for the Treatment of Acne Scars N/A
Completed NCT03522922 - Efficacy of Microneedling With Topical Vitamin C in Treatment of Acne Scarring Phase 1/Phase 2
Recruiting NCT05987319 - Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions N/A