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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04254601
Collaborator
(none)
45
Enrollment
1
Location
3
Arms
14.9
Actual Duration (Months)
3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Narrow band ultraviolet B.
  • Drug: topical erythromycin cream 2% (Akne-Mycin- Egypt)
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The present study is a pretest-post test single blind randomized controlled trial, conducted at Faculty of Physical Therapy, Cairo University.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)
Primary Purpose:
Treatment
Official Title:
Red Low Level LASER Versus Narrow Band Ultraviolet B in the Treatment of Facial Acne Vulgaris
Actual Study Start Date :
Apr 1, 2018
Actual Primary Completion Date :
Jun 30, 2019
Actual Study Completion Date :
Jun 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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).

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

    • 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
    Experimental: 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.

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

    • 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
    Active Comparator: 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.

    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

    Outcome Measures

    Primary Outcome Measures

    1. formal counts of active acne lesions. [8 weeks.]

      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

    1. facial photographic method. [8 weeks.]

      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.

    Other Outcome Measures

    1. lesion count changed percentage. [8 weeks.]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 .

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo university. Cairo Egypt 0025

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hadaya Mosaad, Principal investigator., Cairo University
    ClinicalTrials.gov Identifier:
    NCT04254601
    Other Study ID Numbers:
    • P.T.REC/012/001693
    First Posted:
    Feb 5, 2020
    Last Update Posted:
    Feb 5, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:
    Acne Vulgaris
    Skin Diseases
    Erythromycin
    Erythromycin Estolate
    Erythromycin Ethylsuccinate
    Erythromycin stearate

    Study Results

    No Results Posted as of Feb 5, 2020