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
About this trial
This is an interventional treatment trial for Acne Vulgaris
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.
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
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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