Laser Therapy Versus Narrow Band Ultraviolet B for the Treatment of Acne Vulgaris

Skin Diseases Clinical Trial

— LLLT-NBUB  

Official title:

Red Low Level LASER Versus Narrow Band Ultraviolet B in the Treatment of Facial Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04254601
• Other study ID #: P.T.REC/012/001693
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: February 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Acne Vulgaris
• Skin Diseases

Intervention

Device:
• Narrow band ultraviolet B.
NBUB: DIXWELL EMLY 98 -ABRP 64 ,made in France. Red LLL, InGaAs (630 nm, 10 mW, continuous) (RIKTA, Russia)

Drug:
• 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 . The face is washed thoroughly with warm water and gentle soap, rinse well, and pat dry, patients were advised to wait 30 minutes before applying the aknemycin. To help keep new pimples from breaking out, the aknemycin was applied to the whole area usually affected by acne, not just to the pimples themselves

Locations

Country	Name	City	State
Egypt	Cairo university.	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	lesion count changed percentage.	Five-point scale of investigators assessment that reflect lesion count changed percentage; worse: < - 10 percent, no change:_9percent-9percent, mild improvement: 10percent-39percent, moderate improvement: 40percent-59percent, marked improvement: 60percent-89percent, and clearance: =-90percent.	8 weeks.
Primary	formal counts of active acne lesions.	The lesion number was individually counted by lesion type at all three times of evaluation as the number of papules and pustules	8 weeks.
Secondary	facial photographic method.	facial photographs using a digital camera (PANASONIC, Tokyo, Japan). Photos of the front and bilateral sides of the face were clinically taken each time, by same manner at all time points.	8 weeks.