NCT06909344

Brief Summary

The aim of this study is to evaluate the clinical efficacy and safety of the 577 nm diode laser in the treatment of non -inflammatory acne.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

March 29, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 3, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

April 3, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

March 27, 2025

Last Update Submit

March 27, 2025

Conditions

Acne

Outcome Measures

Primary Outcomes (1)

  • Reduction in the number of comedones, measured through clinical assessment before and after treatment

    3 months

Study Arms (2)

All patients will be treated with sessions of the 577 nm Diode laser on one side of the face

ACTIVE COMPARATOR

All patients will be treated with sessions of the 577 nm Diode laser on one side of the face and on the other side serve as a control

Device: 577 nm Diode laser

other side of the face serve as a control arm without interventions

NO INTERVENTION

All patients will be treated with sessions of the 577 nm Diode laser on one side of the face and on the other side serve as a control without any interventions

Interventions

577 nm Diode laserDEVICE

All patients will be treated with sessions of the 577 nm Diode laser on one side of the face and on the other side serve as a control

All patients will be treated with sessions of the 577 nm Diode laser on one side of the face

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with acne comedones
  • Patients' ages range from 18-40 years.
  • Minimum 10 comedonal lesions on both half of the face

You may not qualify if:

  • Patients with systemic disease interfere with healing.
  • Patients with Photosensitivity.
  • Pregnant or lactating females.
  • Previous topical, systemic, laser, surgical treatment and comedogenic drugs in the last 3 months.
  • Skin cancer or suspicious lesions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azhar Assuit university hospital

Asyut, Assuit, 71511, Egypt

RECRUITING

Related Publications (4)

  • Barbieri JS, Spaccarelli N, Margolis DJ, James WD. Approaches to limit systemic antibiotic use in acne: Systemic alternatives, emerging topical therapies, dietary modification, and laser and light-based treatments. J Am Acad Dermatol. 2019 Feb;80(2):538-549. doi: 10.1016/j.jaad.2018.09.055. Epub 2018 Oct 5.

    PMID: 30296534BACKGROUND

  • Mavranezouli I, Daly CH, Welton NJ, Deshpande S, Berg L, Bromham N, Arnold S, Phillippo DM, Wilcock J, Xu J, Ravenscroft JC, Wood D, Rafiq M, Fou L, Dworzynski K, Healy E. A systematic review and network meta-analysis of topical pharmacological, oral pharmacological, physical and combined treatments for acne vulgaris. Br J Dermatol. 2022 Nov;187(5):639-649. doi: 10.1111/bjd.21739. Epub 2022 Aug 22.

    PMID: 35789996BACKGROUND

  • Melnik BC. Acne Transcriptomics: Fundamentals of Acne Pathogenesis and Isotretinoin Treatment. Cells. 2023 Nov 10;12(22):2600. doi: 10.3390/cells12222600.

    PMID: 37998335BACKGROUND

  • Alsohaimi AO, Alghamdi A, Alghamdi RS, Alghamdi AH, Alkhathami AM, Alghamdi MA, Alghamdi SA, Alzahrani NM, Alghamdi NS. Prevalence of Acne Vulgaris in Adolescents and Young Adults in Al-Baha Region, Saudi Arabia. Cureus. 2024 Oct 12;16(10):e71293. doi: 10.7759/cureus.71293. eCollection 2024 Oct.

    PMID: 39529772BACKGROUND

Related Links

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Central Study Contacts

Hala Hasan Shehata, resident of dermatology

CONTACT

+201142490157halahassan543@gmail.com

Essam El Din Mohamed Mohamed, Professor of Dermatology

CONTACT

+201001470452

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident physician at dermatology department at azhar assuit university hospital

Study Record Dates

First Submitted

March 27, 2025

First Posted

April 3, 2025

Study Start

March 29, 2025

Primary Completion

July 1, 2025

Study Completion

August 1, 2025

Last Updated

April 3, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)