Acne VulgarisPhase 4NCT05296460
DAPSONE GEL7.5%Versus Trichloroacetic Acid 20% ON ACNE VULGARIS
A Phase 4 study testing Dapsone gel in people with Acne Vulgaris, run by Assiut University.
Trial 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 . Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Dapsone gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to Oct 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Dapsone Gel 7.5%in Comparison to Trichloroacetic Acid 20% for Treatment of Acne Vulgaris :Split Face Study
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).
Read the 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
- Being tested
- Dapsone gel
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapsone gelDrug
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
| Study group | Role | What they receive |
|---|---|---|
| dapsone gel and trichloroacetic acid | Experimental | trichloroacetic acid peeling on right side of face and dapsone gel on left side Receives: Drug: Dapsone gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Sep 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Ramadan Bestawy, Assiut University
- Investigators
- dalia attallah, pof dr, Study director, assiut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296460
- Sponsor's protocol ID
- DAPTCA
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Atallah DA, Bestawy SR, Abouelmajd SA, Badran AY. Dapsone 7.5% Gel Versus Trichloroacetic Acid Peels. Dermatol Surg. 2026 May 1;52(5):458-463. doi: 10.1097/DSS.0000000000004896. Epub 2025 Oct 3.
PubMed 41042170
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dapsone Gel 7.5%in Comparison to Trichloroacetic Acid 20% for Treatment of Acne Vulgaris :Split Face Study
- ClinicalTrials.gov ID
- NCT05296460
- Acronym / sponsor ID
- DAPTCA
- Conditions
- Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dapsone gel and trichloroacetic acid | Experimental | Drug: Dapsone geltrichloroacetic acid peeling on right side of face and dapsone gel on left side |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapsone gelThe 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 | Drug | dapsone gel and trichloroacetic acid |
Primary outcome
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
Time frame: 12 weeks
assessment of tolerability:interviewing the patients about any sign/symptoms of adverse reactions(erythema,peeling,burning sensation,dryness and pruritus)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Derived from this study: PubMed 41042170Atallah DA, Bestawy SR, Abouelmajd SA, Badran AY. Dapsone 7.5% Gel Versus Trichloroacetic Acid Peels. Dermatol Surg. 2026 May 1;52(5):458-463. doi: 10.1097/DSS.0000000000004896. Epub 2025 Oct 3.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
dalia attallah, pof dr study director
assiut
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapsone gel in people with Acne Vulgaris, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sahar bestawy, doctor (00201123724467, saharramadan800@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05296460, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.