NCT05296460

Brief Summary

Acne vulgaris, a chronic inflammatory skin disorder, is one of the most prevalent diseases that effects more than 80% of the population worldwide . A variety of factors such as genetics, hormones, infections, as well as environmental factors have been identified as the causes of acne development . Acne usually generates as a result of blockage in the pilosebaceous unit (including hair follicle, hair shaft, and sebaceous gland) due to the over-produced sebum by sebaceous gland, which further triggers the excessive proliferation of the bacterium Propionibacterium acnes (P. Acnes).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2022

Shorter than P25 for phase_4

Status
unknown

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 16, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

March 16, 2022

Last Update Submit

March 24, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Efficacy of the medication:number of inflammatory ,non inflammatory and total lesions. counting the number of inflammatory ,non inflammatory and total lesions at baseline and every 4 weeks during the treatment

    assessment of tolerability:interviewing the patients about any sign/symptoms of adverse reactions(erythema,peeling,burning sensation,dryness and pruritus)

    12 weeks

Study Arms (1)

dapsone gel and trichloroacetic acid

EXPERIMENTAL

trichloroacetic acid peeling on right side of face and dapsone gel on left side

Drug: Dapsone gel

Interventions

The patients will use topical dapsone gel 7.5% once daily on left side of face ,The patients will use TCA20% peeling as a peeling session every 2 weeks (6 sessions) on right side of face

dapsone gel and trichloroacetic acid

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Both males and females will be included.
  • Patients older than 12 years of age.
  • Patients with mild and moderate AV.
  • Patients had not received any topical or systemic treatment for AV during the previous 2 weeks

You may not qualify if:

  • Severe acne.
  • Patients under treatment with contraceptive pills or any kind of systemic or topic acne medication (isotretinoin, antibiotics, topical products).
  • History of hypertrophic/keloid scar formation.
  • Pregnancy, breast feeding.
  • Recurrent herpes infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Atallah DA, Bestawy SR, Abouelmajd SA, Badran AY. Dapsone 7.5% Gel Versus Trichloroacetic Acid Peels. Dermatol Surg. 2025 Oct 3. doi: 10.1097/DSS.0000000000004896. Online ahead of print.

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • dalia attallah, pof dr

    assiut

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 16, 2022

First Posted

March 25, 2022

Study Start

September 1, 2022

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

April 1, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share