Laser Therapy Versus Narrow Band Ultraviolet B for the Treatment of Acne Vulgaris (LLLT-NBUB)

Cairo University (CU)

Status: Completed

Conditions: Skin Diseases

Treatments: Device: Narrow band ultraviolet B.; Drug: topical erythromycin cream 2% (Akne-Mycin- Egypt)

Study type: Interventional

Funder types: Other

Identifiers

NCT04254601

P.T.REC/012/001693

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Experimental group 1

Experimental group

Description:

Patients in group (A) consisted of 15 participants, received a program of NBUB, DIXWELL EMLY 98 -ABRP 64 ,made in France (wavelength 311 to 313nm) , in addition to topical aknemycin medications (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 after 8 weeks).

Treatment:

Drug: topical erythromycin cream 2% (Akne-Mycin- Egypt)

Device: Narrow band ultraviolet B.

Experimental group 2

Experimental group

Description:

Participants in-group (B) consisted of 15 participants, 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 Plus 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.

Treatment:

Drug: topical erythromycin cream 2% (Akne-Mycin- Egypt)

Device: Narrow band ultraviolet B.

Control group

Active Comparator group

Description:

Patients in the group C, consisted of 15 participants, 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.

Treatment:

Drug: topical erythromycin cream 2% (Akne-Mycin- Egypt)