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

NCT ID: NCT04254601

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2019-06-30

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.

Conditions

Skin Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group 1

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).

Group Type: EXPERIMENTAL

Narrow band ultraviolet B.

Intervention Type: DEVICE

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

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

Intervention Type: DRUG

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

Experimental group 2

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.

Group Type: EXPERIMENTAL

Narrow band ultraviolet B.

Intervention Type: DEVICE

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

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

Intervention Type: DRUG

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

Control group

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Interventions

Narrow band ultraviolet B.

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

Intervention Type: DEVICE

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

Intervention Type: DRUG

Other Intervention Names

Red low level laser.

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 .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hadaya Mosaad

Principal investigator.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo university.

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 34015228 (View on PubMed)

Other Identifiers

P.T.REC/012/001693

Identifier Type: -

Identifier Source: org_study_id