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Completed

NCT Number: NCT05622253

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.

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Key information

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reham Essam

Zagazig, Al Sharqia, 2543, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.
  • Pregnant females as well as females who intend to become pregnant during treatment 6. Hypertrophic scar or keloid. 7. Active or recurrent herpes simplex.

Treatment and study plan

Combined Low-Dose Isotretenion and Long-Pulsed 1064 ND-YAG Laser

Combination Product

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 outcomes

  1. The degree of acne erythema was determined on the 4-point grading of acne erythema

    Time frame: 4 months

    0 None Clear

    • Mild Faintly detectable erythema, light pink
    • Moderate Dull red, clearly distinguishable
    • severe Deep/dark red

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2022
Registry last updated
Apr 4, 2023

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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