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

NCT05622253 | Completed

• 1 other identifier: 5566-RE
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

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

  0 None Clear 1. Mild Faintly detectable erythema, light pink 2. Moderate Dull red, clearly distinguishable 3. severe Deep/dark red

  4 months

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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.

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

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. Adult Patients with acne 2. Patients of both sexes. 3. Willing to sign an informed consent

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Reham Essam

Zagazig, Al Sharqia, 2543, Egypt

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Reham Essam, MD

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Dermatology

Study Record Dates

• First Submitted: November 12, 2022
• First Posted: November 18, 2022
• Study Start: March 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)