Clinical trial NCT04254601: Laser Therapy Versus Narrow Band Ultraviolet B for the Treatment of Acne Vulgaris
Official title: Red Low Level LASER Versus Narrow Band Ultraviolet B in the Treatment of Facial Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Diseases
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study is a pretest-post test single blind randomized controlled trial, conducted at Faculty of Physical Therapy, Cairo University.
Primary purpose: TREATMENT

Brief summary: Forty-five participants with facial AV were assigned randomly to three groups of fifteen subjects each. Each group received various therapies. Group A (Study group A) had received both NBUB and akne-Mycin; Group B( study group B) had received Red LLLT and akne-Mycin and group C (Control group) received only akne-Mycin cream. All 45 participants are tested at the initial treatments, after 4 weeks and after 8 weeks by the acne count, the intensity scale and the photographic test.

Detailed description: Forty-five patient (18 male and 27 female) were recruited on a referral basis from the department of dermatology at Kasr Al- aini Teaching Hospital. Firstly, an interview was held with each participant to determine gender, age, skin type, acne severity and medical prescriptions,Randomization was performed by selecting numbers from opaque envelopes containing numbers that were chosen by a random number generator, selection was done by an independent person.

Patients in group (A) received a program of NBUB, ( DIXWELL EMLY 98 -ABRP 64 ,made in France) wavelength 311 to 313nm , in addition to topical aknemycin medications. Each treatment lasts one to eight minutes. The treatments were given three times a week. for 8 weeks.Participants in-group (B) received a program of R-LLLT that was conducted through laser equipment InGaAs (630 nm, 10 mW, continuous) (RIKTA, Russia) with fluence 12 J/cm2, two sessions per week for 8 weeks .Patients in the three groups were asked to apply topical erythromycin cream 2% (Akne-Mycin- Egypt) two times per day on the entire face from the beginning to the end of the treatment period .Evaluation was based on formal counts of active lesions (papule and pustule).facial photographs using a digital camera (PANASONIC, Tokyo, Japan). and Five-point scale of investigators assessment that reflect lesion count improved percentage.

Eligibility criteria: Inclusion Criteria:

* Ages ranged from 18-35 years.
* Skin type III and IV.
* Mild to moderate facial acne.

Exclusion Criteria:

* Treatment with oral retinoid within past 1 year.
* Treatment with other acne treatment within past 3 months.
* History of treatment with systemic and topical antibiotics for acne vulgaris within the last 1 month.
* Treatment with oral isotretinoin within the last 6 months.
* Participants received radiotherapy or chemotherapy.
* Any history of photosensitivity.
* Chemical peels during the previous 4 weeks.
* Seizures,
* Pregnancy
* Use of oral contraceptives.
* Breastfeeding .

Primary outcomes:
measure: formal counts of active acne lesions.
timeFrame: 8 weeks.
Secondary outcomes:
measure: facial photographic method.
timeFrame: 8 weeks.
Other outcomes:
measure: lesion count changed percentage.
timeFrame: 8 weeks.
Locations:
city: Cairo
country: Egypt
facility: Cairo university.
Study officials:
References:
citation: Eid MM, Saleh MS, Allam NM, Elsherbini DM, Abdelbasset WK, Eladl HM. Narrow Band Ultraviolet B Versus Red Light-Emitting Diodes in the Treatment of Facial Acne Vulgaris: A Randomized Controlled Trial. Photobiomodul Photomed Laser Surg. 2021 Jun;39(6):418-424. doi: 10.1089/photob.2020.4988. Epub 2021 May 20.