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

NCT04254601 | Completed

• 1 other identifier: P.T.REC/012/001693
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• facial photographic method.

  8 weeks.

Other Outcomes (1)

• lesion count changed percentage.

  8 weeks.

Study Arms (3)

Experimental group 1

EXPERIMENTAL

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).

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

Experimental group 2

EXPERIMENTAL

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.

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

Control group

ACTIVE COMPARATOR

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.

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

Interventions

Narrow band ultraviolet B. DEVICE

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

Also known as: Red low level laser.

Experimental group 1; Experimental group 2

topical erythromycin cream 2% (Akne-Mycin- Egypt) 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; Experimental group 1; Experimental group 2

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university.

Cairo, 0025, Egypt

Location

Related Publications (1)

• 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.

  PMID: 34015228 DERIVED

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator.

Model Details: The present study is a pretest-post test single blind randomized controlled trial, conducted at Faculty of Physical Therapy, Cairo University.

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: April 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: we will share the study after 6 months of publication.

Locations

EG (1)