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Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser in the Treatment of Acne Erythema

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

16 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 1. Adult Patients with acne 2. Patients of both sexes. 3. Willing to sign an informed consent Exclusion Criteria: - 1. Patients who were taking concomitant acne medication 2. Patients had a history of topical or systemic therapy use for acne for the past 6 months, 3. Patients with a history of photosensitivity reactions 4. Patients with any renal or hepatic compromise or any preexisting hyperlipidemia. 5. Pregnant females as well as females who intend to become pregnant during treatment 6. Hypertrophic scar or keloid. 7. Active or recurrent herpes simplex.

Sites / Locations

  • Reham Essam

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser in the Treatment of Acne Erythema

Arm Description

Selected patients will be treated with low-dose oral isotretinoin (10mg/day) over a period of sessions and six sessions of 1064 ND- YAG laser (Deka motous AY) using 150 J/cm2, 20-25 milliseconds pulse duration, and 5 mm spot size, at 2 weeks' interval.

Outcomes

Primary Outcome Measures

The degree of acne erythema was determined on the 4-point grading of acne erythema
0 None Clear Mild Faintly detectable erythema, light pink Moderate Dull red, clearly distinguishable severe Deep/dark red

Secondary Outcome Measures

Full Information

First Posted
November 12, 2022
Last Updated
April 3, 2023
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT05622253
Brief Title
Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser in the Treatment of Acne Erythema
Official Title
Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser in the Treatment of Acne Erythema
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Acne erythema consists of telangiectasia and erythematous papules, without a comedo, which occurs as a result of inflammatory acne. Moreover, although acne erythema is common in acne patients, no satisfactory medical or surgical treatment is available for this condition. Some acne erythema lesions may improve with time, but the persistent acne erythema, which is experienced by most patients, is cosmetically unacceptable and leads to frustration and psychological distress.
Detailed Description
Up to the present time, there have been several studies on the clinical efficacy of different laser modalities for acne treatment. Pulsed dye laser (PDL), 585 or 595 nm, has been demonstrated as one of the effective treatment options Another laser long-pulsed neodymium: yttrium-aluminum-garnet (Nd:YAG) laser with 1064 nm has been commonly used for skin rejuvenation. Nevertheless, the efficacy of this laser for acne treatment has been shown in some studies and case reports. The therapeutic effect on acne lesions is believed to be mediated by the selective photothermolysis of vessels, the upregulation of TGF-β, the reduction of interleukin-8 (IL-8) and Toll-like receptors-2 (TLR-2), and the thermal destruction of sebaceous glands. Isotretinoin remains the mainstay of acne treatment. No doubt, the side effects of this effective drug holds physicians back from jumping to prescribe it. Recent data suggested that lower doses (0.25 mg/kg/day) may lead to fewer side effects. and fewer flares. Clearing the use of oral isotretinoin in combination with other procedures has expanded our therapeutic options to obtain better control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser in the Treatment of Acne Erythema
Arm Type
Experimental
Arm Description
Selected patients will be treated with low-dose oral isotretinoin (10mg/day) over a period of sessions and six sessions of 1064 ND- YAG laser (Deka motous AY) using 150 J/cm2, 20-25 milliseconds pulse duration, and 5 mm spot size, at 2 weeks' interval.
Intervention Type
Combination Product
Intervention Name(s)
Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser
Intervention Description
Selected patients will be treated with low-dose oral isotretinoin (10mg/day) over a period of sessions and six sessions of 1064 ND- YAG laser (Deka motous AY) using 150 J/cm2, 20-25 milliseconds pulse duration, and 5 mm spot size, at 2 weeks' interval.
Primary Outcome Measure Information:
Title
The degree of acne erythema was determined on the 4-point grading of acne erythema
Description
0 None Clear Mild Faintly detectable erythema, light pink Moderate Dull red, clearly distinguishable severe Deep/dark red
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. Adult Patients with acne 2. Patients of both sexes. 3. Willing to sign an informed consent Exclusion Criteria: - 1. Patients who were taking concomitant acne medication 2. Patients had a history of topical or systemic therapy use for acne for the past 6 months, 3. Patients with a history of photosensitivity reactions 4. Patients with any renal or hepatic compromise or any preexisting hyperlipidemia. 5. Pregnant females as well as females who intend to become pregnant during treatment 6. Hypertrophic scar or keloid. 7. Active or recurrent herpes simplex.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reham Essam, MD
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reham Essam
City
Zagazig
State/Province
Al Sharqia
ZIP/Postal Code
2543
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser in the Treatment of Acne Erythema

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