- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04254601
Laser Therapy Versus Narrow Band Ultraviolet B for the Treatment of Acne Vulgaris (LLLT-NBUB)
Red Low Level LASER Versus Narrow Band Ultraviolet B in the Treatment of Facial Acne Vulgaris
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 0025
- Cairo university.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 .
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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).
|
NBUB: DIXWELL EMLY 98 -ABRP 64 ,made in France.
Red LLL, InGaAs (630 nm, 10 mW, continuous) (RIKTA, Russia)
Other Names:
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.
|
NBUB: DIXWELL EMLY 98 -ABRP 64 ,made in France.
Red LLL, InGaAs (630 nm, 10 mW, continuous) (RIKTA, Russia)
Other Names:
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.
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
8 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 weeks.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 weeks.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Acneiform Eruptions
- Sebaceous Gland Diseases
- Acne Vulgaris
- Skin Diseases
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Erythromycin
- Erythromycin Estolate
- Erythromycin Ethylsuccinate
- Erythromycin stearate
Other Study ID Numbers
- P.T.REC/012/001693
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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