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DAPSONE GEL7.5%Versus Trichloroacetic Acid 20% ON ACNE VULGARIS

Primary Purpose

Acne Vulgaris

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dapsone gel
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    dapsone gel and trichloroacetic acid

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    Full Information

    First Posted
    March 16, 2022
    Last Updated
    March 24, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05296460
    Brief Title
    DAPSONE GEL7.5%Versus Trichloroacetic Acid 20% ON ACNE VULGARIS
    Official Title
    Efficacy of Dapsone Gel 7.5%in Comparison to Trichloroacetic Acid 20% for Treatment of Acne Vulgaris :Split Face Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    October 2023 (Anticipated)
    Study Completion Date
    October 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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).
    Detailed Description
    Chemical peeling can target the pathogenic factors recognized in acne and treat present primary and secondary lesions, it also improves the pigmentary changes seen with acne, and hastes the time taken to repair skin to normal. Trichloroacetic acid (TCA), salicylic acid (SA), and azelaic acid (AA) have proved efficacy in the treatment of acne as a result of their exfoliative and keratolytic properties . The mechanism of TCA peel in the treatment of acne vulgaris is due to its ability to diminish corneocyte cohesion and keratinocyte plugging, thus helping in comedolytic action. In addition, application of TCA to the skin causes precipitation of proteins and coagulative necrosis of epidermal cells, leading to removal of damaged skin and its replacement by normal tissue. Dapsone is a "4,40-diamino diphenyl sulfone" compound and an aniline derivative from synthetic sulphones.. Sulphonamides were first used in humans as antimicrobial agents to treat streptococcal infections. Dapsone derived from sulphonamides was first used in the treatment of leprosy in 1940 . Subsequently, it was used in the treatment of bullous dermatoses, especially dermatitis herpetiformis, and in the treatment of non-infectious inflammatory dermatoses, especially neutrophilic dermatoses . Today, Dapsone treatment is among the treatment options for many dermatological diseases. Dapsone carries both bacteriostatic and anti-inflammatory properties. Its antimicrobial effect stems from its sulfonamide-like ability to inhibit the synthesis of dihydrofolic acid . Additionally, dapsone has multiple anti-inflammatory properties. It inhibits the production of reactive oxygen species directly and reversibly inhibits the myeloperoxidase enzyme thus decreasing hypochlorous acid formation. further more topical dapsone has been used with different concentration in treating acne vulgaris: both dapsone gel 7.5% and dapsone gel 5%has been used and found to be safe and effective

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acne Vulgaris

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    dapsone gel and trichloroacetic acid
    Arm Type
    Experimental
    Arm Description
    trichloroacetic acid peeling on right side of face and dapsone gel on left side
    Intervention Type
    Drug
    Intervention Name(s)
    Dapsone gel
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    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
    Description
    assessment of tolerability:interviewing the patients about any sign/symptoms of adverse reactions(erythema,peeling,burning sensation,dryness and pruritus)
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    sahar bestawy, doctor
    Phone
    00201123724467
    Email
    saharramadan800@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    aya badran
    Phone
    00201013244819
    Email
    aya_badran@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    dalia attallah, pof dr
    Organizational Affiliation
    assiut
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    DAPSONE GEL7.5%Versus Trichloroacetic Acid 20% ON ACNE VULGARIS

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