Acne Vulgaris
Conditions
Keywords
acne vulgaris
Brief summary
Acne is one of the most common conditions that patients seek for help in dermatological clinic. Nowadays, conventional treatment including topical agents(retinoids, antibiotics ,antiseptics and keratolytic agents) and systemic agents( antibiotics and retinoids) give a satisfying result but not to every patient. Some patients are not well respond to conventional therapy while some patients are unable to tolerate side effects of the treatments. Therefore, interventions to reduce acne are vigorously experimented . Lights and lasers including intense pulsed light, pulsed dye laser with or without photosensitizer and infrared lasers have been found to be useful in treating active inflammatory acne. Although,pain ,downtime and poor response of comedonal acne are limitations of those lights and lasers therapy. 2940 nm Erbium:YAG laser which has both resurfacing and photothermal effects is our laser of interest to seek for its efficacy in the treatment of inflammatory acne.
Interventions
DEVICE2940 nm Er:YAG laser (DualisXS M002-2A, Fotona®, Fotona d.d, Ljubljana, Slovenia)
2 passes of 2940nm Er:YAG laser
2.5% benzoyl peroxide gel apply twice daily on inflammatory acne on the control side of face
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 year-old to 45 year-old * Mild to moderate severity of acne vulgaris with at least 5 active inflammatory acne lesions on each side of the face and less than 25% difference in lesion count between each side of face * Fitzpatrick skin phototype I-IV
Exclusion criteria
* History or clinical presentation of hypertrophic scar or keloid * Photoaggravated skin diseases i.e. systemic lupus erythematosus, polymorphous light eruption, solar urticaria * Oral isotretinoin taken within the last 6 months prior to enrollment * Topical retinoid within 4 weeks prior to enrollment * Systemic acne therapies (oral antibiotics) within 4 week prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage change from baseline of inflammatory acne lesion count at 6 week after 1st 2940nm Er:YAG laser treatment | 6 week | % change from baseline = (NV- NB)/NB x 100% NV = number of lesion at each visit NB = number of lesion at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | week0,2,4 | Safety profile of 2940nm Er:YAG laser for the treatment of inflammatory acne including; * Visual analogue scale of pain score * Adverse events(AEs) include types of AEs(erythema, pain/burning sensation, dryness/excessive scaling, pigmentary change), timing, intenstity, outcome and action taking regarding to study procedure particular subject. |
| Photographic clinical improvement | week 2,4,6 and 10 | Photographic clinical improvement of acne, acne scar, erythema, hyperpigmentation and overall improvement by blinded dermatologists using quartile grading system comparing baseline and each clinical visit (week 2,4,6 and 10) |
| Patient satisfaction | week 6 | Self evaluation of patient satisfaction |
Countries
Thailand
Outcome results
None listed