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

Primary Purpose

Skin Diseases

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Narrow band ultraviolet B.
topical erythromycin cream 2% (Akne-Mycin- Egypt)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Diseases

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept 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 .

Sites / Locations

  • Cairo university.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Experimental group 1

Experimental group 2

Control group

Arm 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).

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
January 31, 2020
Last Updated
February 3, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04254601
Brief Title
Laser Therapy Versus Narrow Band Ultraviolet B for the Treatment of Acne Vulgaris
Acronym
LLLT-NBUB
Official Title
Red Low Level LASER Versus Narrow Band Ultraviolet B in the Treatment of Facial Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The present study is a pretest-post test single blind randomized controlled trial, conducted at Faculty of Physical Therapy, Cairo University.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group 1
Arm Type
Experimental
Arm 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).
Arm Title
Experimental group 2
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Narrow band ultraviolet B.
Other Intervention Name(s)
Red low level laser.
Intervention Description
NBUB: DIXWELL EMLY 98 -ABRP 64 ,made in France. Red LLL, InGaAs (630 nm, 10 mW, continuous) (RIKTA, Russia)
Intervention Type
Drug
Intervention Name(s)
topical erythromycin cream 2% (Akne-Mycin- Egypt)
Intervention Description
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
Primary Outcome Measure Information:
Title
formal counts of active acne lesions.
Description
The lesion number was individually counted by lesion type at all three times of evaluation as the number of papules and pustules
Time Frame
8 weeks.
Secondary Outcome Measure Information:
Title
facial photographic method.
Description
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.
Time Frame
8 weeks.
Other Pre-specified Outcome Measures:
Title
lesion count changed percentage.
Description
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.
Time Frame
8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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 .
Facility Information:
Facility Name
Cairo university.
City
Cairo
ZIP/Postal Code
0025
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
we will share the study after 6 months of publication.
Citations:
PubMed Identifier
34015228
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.
Results Reference
derived

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

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