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Completed

NCT Number: NCT04254601

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

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.

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Key information

Conditions

Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university.

Cairo, 0025, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Narrow band ultraviolet B.

Device

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.

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

Primary outcomes

  1. formal counts of active acne lesions.

    Time frame: 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 outcomes

  1. facial photographic method.

    Time frame: 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 outcomes

  1. lesion count changed percentage.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: LLLT-NBUB

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2020
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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