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

NCT ID: NCT05296460

Last Updated: 2022-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-10-31

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

Conditions

Acne Vulgaris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

dapsone gel and trichloroacetic acid

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

Group Type: EXPERIMENTAL

Dapsone gel

Intervention Type: DRUG

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

Interventions

Dapsone gel

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Sahar Ramadan Bestawy

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

dalia attallah, pof dr

Role: STUDY_DIRECTOR

assiut

Central Contacts

sahar bestawy, doctor

Role: CONTACT

saharramadan800@yahoo.com

00201123724467

aya badran

Role: CONTACT

aya_badran@yahoo.com

00201013244819

References

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.

Reference Type: DERIVED

PMID: 41042170 (View on PubMed)

Other Identifiers

DAPTCA

Identifier Type: -

Identifier Source: org_study_id