AcneNCT07237763
Assessment of the Efficacy of Topical Ketoconazole 2% Cream in Comparison With Topical Retinoids in the Treatment of Mild Comedonal and Papulopustular Acne
A study testing advised to apply topical ketoconazole 2% cream twice daily on the whole face. and topical adapalene to the face in people with Acne, run by Cairo University at 1 site in Egypt.
Trial summary
objective: is to assess the efficacy of topical ketoconazole 2% cream in comparison with topical retinoid in the treatment of mild comedonal and papulopustular acne to determine if ketoconazole can be an alternative to topical retinoid with less side effects and more compliance. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Acne
- What is being tested?
- advised to apply topical ketoconazole 2% cream twice daily on the whole face. and topical adapalene to the face
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with mild comedonal or papulopustular acne with a GEA score from 1-2 on the face.
- Both sexes.
- Age: adolescents and adults.
- Skin type 3 and 4.
Who cannot join
- • Patients using, will use during the study, or discontinued less than 4 weeks before study baseline, prescribed or over-the counter topical therapies for the treatment of acne.
- Patients using, will use during the study, or discontinued less than 4 weeks before study baseline, any facial procedures such as chemical peel, laser treatment or depilation in area of treatment application (except eyebrow shaping).
- Patients with outdoor occupation, exposed to sun and heat.
- Patients using, will use during study any cosmoceuticals.
- Patients using, will use during the study, or discontinued less than 12 weeks before study baseline, systemic therapies for the treatment of acne or any other systemic treatments.
- Patients with other special types of acne or conditions presenting with acne/acneiform eruption.
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- Irregular menstrual cycles or clinically suspected polycystic ovarian syndrome.
- Patients with other facial rashes preventing the accurate assessment.
- Known or suspected allergy to ingredients.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Topical Ketoconazole 2% Cream and Topical Adapalene 2% Cream in the Treatment of Mild Comedonal and Papulopustular Acne, a Randomized Controlled Trial
objective: is to assess the efficacy of topical ketoconazole 2% cream in comparison with topical retinoid in the treatment of mild comedonal and papulopustular acne to determine if ketoconazole can be an alternative to topical retinoid with less side effects and more compliance.
Patients and methods: 52 patients with mild comedonal and papulopustular acne will be randomized into 2 groups and instructed to apply randomly either topical KTZ 2% cream or topical retinoid cream for a period of 12 weeks. Evaluation of response will be done by a blinded investigator
Read the detailed description
Background: Acne vulgaris is a common chronic inflammatory skin disorder of pilosebaceous units that occurs predominantly in the skin of the face, upper chest and upper back. Acne is of multifactorial origin with four main pathophysiologic mechanisms: follicular hyperkeratinization with obstruction of pilosebaceous ducts, hormonal influences on sebum production, cutibacterium acnes (C. acnes) proliferation, immune host reaction and inflammation. Ketoconazole (KTZ) is an imidazolic anti-mycotic derivative that has been recently tried as a new line of treatment of mild acne. KTZ acts on microbial dysbiosis through the inhibitory effect on lipase activity of malassezia species and both antibiotic-susceptible and resistant C. acnes.
Objectives: our objective is to assess the efficacy of topical ketoconazole 2% cream in comparison with topical retinoid in the treatment of mild comedonal and papulopustular acne to determine if ketoconazole can be an alternative to topical retinoid with less side effects and more compliance.
Patients and methods: 52 patients with mild comedonal and papulopustular acne will be randomized into 2 groups. Group A will be advised to apply topical KTZ 2% cream twice daily on the whole face. Group B will be advised to apply topical retinoid cream once daily at night on the whole face except sensitive areas for a period of 12 weeks. Evaluation of response will be done by a blinded investigator 2 weeks after discontinuation of treatment using total lesion count, Global Evaluation of Acne (GEA) scores, Cardiff Acne Disability Index (CADI), and post-inflammatory hyperpigmentation (PIH) scores and patient satisfaction.
- Conditions
- Acne
- Being tested
- advised to apply topical ketoconazole 2% cream twice daily on the whole face., topical adapalene to the face
- Keywords
- ketoconazole, adapalene
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
advised to apply topical ketoconazole 2% cream twice daily on the whole face.Drug
ketoconazole will be applied twice per day on the face for 12 weeks
topical adapalene to the faceDrug
will be advised to apply topical adapalene cream once daily at night on the whole face except sensitive areas for a period of 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| mild acne patients who will apply topical ketoconazole 2% | Active comparator | they will apply topical KTZ 2% cream twice daily on the whole face for 12 weeks Receives: Drug: advised to apply topical ketoconazole 2% cream twice daily on the whole face. |
| mild acne patients who will apply topical adapalene 2% | Active comparator | they will apply topical retinoid cream once daily at night on the whole face except sensitive areas for a period of 12 weeks Receives: Drug: topical adapalene to the face |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the efficacy of topical ketoconazole 2% cream in treatment of mild to moderate acne
results will be assessed using total lesion count
Measured: 3 months
Secondary outcomes (2)
patient satisfaction
evaluation will be on a scale from 1-10
Measured: 3 months
effect on post inflammatory hyperpigemntation
by a subjective score ranging from mild to severe
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start15 Jan 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mostafa Korany Mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237763
- Sponsor's protocol ID
- Dermatology 25
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Topical Ketoconazole 2% Cream and Topical Adapalene 2% Cream in the Treatment of Mild Comedonal and Papulopustular Acne, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07237763
- Acronym / sponsor ID
- Dermatology 25
- Conditions
- Acne
- Keywords
- ketoconazole, adapalene
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Nov 2025 (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.
objective: is to assess the efficacy of topical ketoconazole 2% cream in comparison with topical retinoid in the treatment of mild comedonal and papulopustular acne to determine if ketoconazole can be an alternative to topical retinoid with less side effects and more compliance.
Patients and methods: 52 patients with mild comedonal and papulopustular acne will be randomized into 2 groups and instructed to apply randomly either topical KTZ 2% cream or topical retinoid cream for a period of 12 weeks. Evaluation of response will be done by a blinded investigator
Detailed description
Background: Acne vulgaris is a common chronic inflammatory skin disorder of pilosebaceous units that occurs predominantly in the skin of the face, upper chest and upper back. Acne is of multifactorial origin with four main pathophysiologic mechanisms: follicular hyperkeratinization with obstruction of pilosebaceous ducts, hormonal influences on sebum production, cutibacterium acnes (C. acnes) proliferation, immune host reaction and inflammation. Ketoconazole (KTZ) is an imidazolic anti-mycotic derivative that has been recently tried as a new line of treatment of mild acne. KTZ acts on microbial dysbiosis through the inhibitory effect on lipase activity of malassezia species and both antibiotic-susceptible and resistant C. acnes.
Objectives: our objective is to assess the efficacy of topical ketoconazole 2% cream in comparison with topical retinoid in the treatment of mild comedonal and papulopustular acne to determine if ketoconazole can be an alternative to topical retinoid with less side effects and more compliance.
Patients and methods: 52 patients with mild comedonal and papulopustular acne will be randomized into 2 groups. Group A will be advised to apply topical KTZ 2% cream twice daily on the whole face. Group B will be advised to apply topical retinoid cream once daily at night on the whole face except sensitive areas for a period of 12 weeks. Evaluation of response will be done by a blinded investigator 2 weeks after discontinuation of treatment using total lesion count, Global Evaluation of Acne (GEA) scores, Cardiff Acne Disability Index (CADI), and post-inflammatory hyperpigmentation (PIH) scores and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mild acne patients who will apply topical ketoconazole 2% | Active comparator | Drug: advised to apply topical ketoconazole 2% cream twice daily on the whole face.they will apply topical KTZ 2% cream twice daily on the whole face for 12 weeks |
| mild acne patients who will apply topical adapalene 2% | Active comparator | Drug: topical adapalene to the facethey will apply topical retinoid cream once daily at night on the whole face except sensitive areas for a period of 12 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with mild comedonal or papulopustular acne with a GEA score from 1-2 on the face.
- Both sexes.
- Age: adolescents and adults.
- Skin type 3 and 4.
Key exclusion criteria (10 listed)
- • Patients using, will use during the study, or discontinued less than 4 weeks before study baseline, prescribed or over-the counter topical therapies for the treatment of acne.
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 |
|---|---|---|
| advised to apply topical ketoconazole 2% cream twice daily on the whole face.ketoconazole will be applied twice per day on the face for 12 weeks | Drug | mild acne patients who will apply topical ketoconazole 2% |
| topical adapalene to the facewill be advised to apply topical adapalene cream once daily at night on the whole face except sensitive areas for a period of 12 weeks | Drug | mild acne patients who will apply topical adapalene 2% |
Primary outcome
To study the efficacy of topical ketoconazole 2% cream in treatment of mild to moderate acne
Time frame: 3 months
results will be assessed using total lesion count
2 secondary outcomes
patient satisfaction
Time frame: 3 months
effect on post inflammatory hyperpigemntation
Time frame: 3 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing advised to apply topical ketoconazole 2% cream twice daily on the whole face. and topical adapalene to the face in people with Acne, run by Cairo University at 1 site in Egypt.
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 10 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: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the efficacy of topical ketoconazole 2% cream in treatment of mild to moderate acne (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2025.