A Study of a Laser for the Treatment of Acne Vulgaris
The purpose of this study is to evaluate the onset, duration, efficacy and safety of the laser for the treatment of acne vulgaris.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||16 Years - 50 Years|
- - Female or Male, 16 to 50 years of age (inclusive).
- - Fitzpatrick Skin Type I-VI.
- - Has clinically diagnosed acne vulgaris of moderate to severe on each hemiface and inflammatory acne lesions as determined by the blinded trained investigator (or qualified designee) using the Investigator's Global Assessment Scale.
- - Subject (and legally authorized representative/substitute decision maker if subject is incapable of providing informed consent) must be able to read, speak, and understand English and sign the Informed Consent Form.
- - Willing to stop using topical acne medications on the face for 2 weeks prior to baseline and systemic acne medications for 1 month prior to baseline and for the duration of the study.
- - Willing and able to adhere to the treatment and follow-up schedule and pre/post-treatment care instructions.
- - Willing to have very limited sun exposure (including avoiding tanning booths, sun lamps, sunbathing) and use an approved sunblock or sunscreen of SPF (Skin Protection Factor) 30 or higher on the face every day for the duration of the study, including the follow-up period.
- - Willing to have photographs taken of the face and agree to the use of photographs for presentation, educational or marketing purposes.
- - Agree to not undergo any other procedure(s) or add any new treatment modalities in the target area during the study.
- - Has clinically diagnosed acne vulgaris of severity grade of clear, almost clear, or mild on at least one hemiface as determined by the blinded trained investigator (or qualified designee) using the Investigator's Global Assessment Scale.
- - Prior treatment to the target area during participation in a clinical trial of another device or drug within 1 month (30 days) prior to study participation.
- - Prior treatment to the target area within 1 month of study participation including chemical peel, dermabrasion/microdermabrasion, microneedling, radiofrequency treatment, laser or light-based procedures, cryodestruction or chemodestruction, intralesional steroids, photodynamic therapy, or acne surgery.
- - Prior injection of botulinum toxin in the target area within 1 month of study participation and for the duration of the study.
- - Prior injection of collagen, hyaluronic acid filler or other dermal/tissue filler in the target area within 2 weeks of study participation.
- - Systemic use of retinoid, such as isotretinoin, within 6 months of study participation.
- - Started or changed hormonal contraception within 6 months of study participation or intends to start or change hormonal contraception through duration of the study.
- - History of malignant tumors in the target area.
- - Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) or facial adornments (studs, piercings, tattoos) that may preclude treatments, photos or accurate lesion assessments in the target area.
- - Pregnant and/or breastfeeding or planning to become pregnant during the study.
- - Presence of any skin condition in the target area (e.g., eczema, psoriasis, dermatitis, rash, papulo-pustular rosacea, infection) that would interfere with the diagnosis or assessment of acne vulgaris.
- - Any medical condition that, in the opinion of the Investigator, would interfere with patient's participation in the full study protocol (e.g., severe Diabetes Mellitus or Cardiovascular Disease).
- - Suffering from diagnosed coagulation disorders or taking prescription anticoagulation medications.
- - History of diagnosed immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- - History of diagnosed connective tissue disease, such as systemic lupus erythematosus or scleroderma.
- - Known hypersensitivity to, history of allergic reaction to, or contraindication to Pro-Nox (or similar) if administered.
- - Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
- - History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the target area, unless treatment is conducted following a prophylactic regimen.
- - History of radiation to the target area, currently undergoing treatment for skin cancer in the target area or undergoing systemic chemotherapy for the treatment of cancer.
- - History of diagnosed pigmentary disorders (including vitiligo) in the target area.
- - Facial tan or unable/unlikely to refrain from tanning on the face during the study.
- - As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: 1726nm Laser Treatment
Sham Comparator: Sham Laser Treatment
Device: - 1726nm Laser System
Subjects will receive 1726nm laser treatments on one side of the face
Device: - Sham Laser System
Subjects will receive sham laser treatments on the other side of the face.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Canadian Dermatology Centre
Toronto, Ontario, M3B 0A7
Windsor Clinical Research
Windsor, Ontario, N8W 5L7