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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Combination product: Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al Sharqia
    • Zagazig, Al Sharqia, Egypt, 2543
      • Reham Essam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser in the Treatment of Acne Erythema; 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.	Combination product: Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 months

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: November 12, 2022
• First Submitted That Met QC Criteria: November 12, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Acneiform Eruptions; Sebaceous Gland Diseases; Erythema; Acne Vulgaris
• Other Study ID Numbers: 5566-RE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No