Acne VulgarisPhase 4NCT07915648
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
A Phase 4 study testing nadifloxacin, Tretinoin Cream 0.025% and Clindamycin in people with Acne Vulgaris, run by Nishtar Medical University at 1 site in Pakistan.
Trial summary
The purpose of this randomized controlled trial is to compare the effectiveness of two topical combination treatments for mild-to-moderate acne vulgaris: 1% nadifloxacin with 0.025% tretinoin cream versus 1% clindamycin with 0.025% tretinoin cream. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- nadifloxacin, Tretinoin Cream 0.025% and Clindamycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Sep 2026to 16 Mar 2027
- Phase
- Phase 4
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- newly diagnosed with acne vulgaris
- mild to moderate severity
Who cannot join
- Drug induced acne or acneiform eruptions (corticosteroids, antiepileptics, lithium, iodides)
- endocrine disorders (PCOS, Cushing syndrome, congenital adrenal hyperplasia)
- chronic dermatological conditions affecting face (Rosacea, seborrheic dermatitis, perioral dermatitis)
- pregnant or lactating women
- chronic systemic illness (chronic liver disease, kidney disease)
- patients with known hypersensitivity to study medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Nishtar Medical University and Hospital
Multan, Punjab Province, 60000
Muhammad T Suleman, MBBS, +92 331 7291061, talha.cascade@gmail.com
Raheel T Associate Professor, FCPS, +92 300 6332846, raheeldermatology1231@gmail.com
About this study
Official title: Comparison of Efficacy of Topical Nadifloxacin With Tretinoin Versus Clindamycin With Tretinoin in Mild-to-Moderate Acne.
The purpose of this randomized controlled trial is to compare the effectiveness of two topical combination treatments for mild-to-moderate acne vulgaris: 1% nadifloxacin with 0.025% tretinoin cream versus 1% clindamycin with 0.025% tretinoin cream. The study will be conducted in the Department of Dermatology, Nishtar Hospital, Multan, and will enroll adults aged 18 to 40 years of either gender who are newly diagnosed with mild-to-moderate acne vulgaris. Participants with drug-induced acne, endocrine disorders (such as PCOS), other chronic facial skin conditions, pregnancy or lactation, chronic systemic illness, or known hypersensitivity to the study medications will be excluded.
Participants will be randomly assigned to one of two groups, with allocation concealed using sealed opaque envelopes. Group A will apply nadifloxacin plus tretinoin cream, and Group B will apply clindamycin plus tretinoin cream. In both groups, a thin layer of the assigned cream will be applied once daily at bedtime to the whole affected area after washing the face with a mild cleanser. Participants will also be advised to use a non-comedogenic moisturizer and sunscreen and to avoid other acne treatments. Follow-up visits will take place at 4, 8, and 12 weeks, with medication use checked by inspecting returned tubes and side effects (redness, dryness, peeling, burning, itching, allergic reactions) recorded at each visit.
Read more
At baseline and after 12 weeks of treatment, a consultant dermatologist who is unaware of the treatment assigned will count inflammatory, non-inflammatory, and total lesions and grade acne severity using the Global Acne Grading System. The main outcome is the reduction in the number of inflammatory lesions after 12 weeks. Secondary outcomes are the reduction in non-inflammatory and total lesions, change in acne severity grade, and side effects.
The study hypothesizes that the reduction in inflammatory lesions at 12 weeks is greater with nadifloxacin plus tretinoin than with clindamycin plus tretinoin.
- Conditions
- Acne Vulgaris
- Being tested
- nadifloxacin, Tretinoin Cream 0.025%, Clindamycin
- Keywords
- Acne vulgaris, Nadifloxacin, Clindamycin, Tretinoin, Topical combination therapy, Inflammatory lesions, Non-inflammatory lesions, Global Acne Grading System, Mild-to-moderate acne, Topical antibiotics, Topical retinoid
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nadifloxacinDrug
Topical 1% nadifloxacin cream
Tretinoin Cream 0.025%Drug
Topical Tretinoin Cream 0.025%
ClindamycinDrug
Topical Clindamycin 1% cream
| Study group | Role | What they receive |
|---|---|---|
| Nadifloxacin 1% plus Tretinoin 0.025% Cream | Experimental | After washing the face with a mild cleanser and allowing the skin to dry for 20 to 30 minutes, a thin layer of 1% nadifloxacin combined with 0.025% tretinoin topical cream will be applied once daily at bedtime to the entire acne-affected area, avoiding the eyes, lips, and mucosal surfaces. Participants use a non-comedogenic moisturizer and sunscreen during the day and avoid other topical acne treatments. Treatment continues for 12 weeks Receives: Drug: nadifloxacin; Drug: Tretinoin Cream 0.025% |
| Clindamycin 1% plus Tretinoin 0.025% Cream | Active comparator | After washing the face with a mild cleanser and allowing the skin to dry for 20 to 30 minutes, a thin layer of 1% clindamycin combined with 0.025% tretinoin topical cream will be applied once daily at bedtime to the entire acne-affected area, avoiding the eyes, lips, and mucosal surfaces. Participants use a non-comedogenic moisturizer and sunscreen during the day and avoid other topical acne treatments. Treatment continues for 12 weeks Receives: Drug: Tretinoin Cream 0.025%; Drug: Clindamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in number of inflammatory acne lesions
Change in the number of inflammatory lesions (papules, nodules, pustules), calculated as the difference between the baseline count and the count at 12 weeks. Lesions are counted by a consultant dermatologist blinded to the treatment assigned.
Measured: From randomization to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start17 Sep 2026
- Primary completion16 Mar 2027 (estimated)
- Study completion16 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nishtar Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Talha Suleman, Nishtar Medical University
- Investigators
- Raheel T Associate Professor, FCPS, Study chair, Nishtar Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915648
- Sponsor's protocol ID
- U1111-1348-8715
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Topical Nadifloxacin With Tretinoin Versus Clindamycin With Tretinoin in Mild-to-Moderate Acne.
- ClinicalTrials.gov ID
- NCT07915648
- Acronym / sponsor ID
- U1111-1348-8715
- Conditions
- Acne Vulgaris
- Keywords
- Acne vulgaris, Nadifloxacin, Clindamycin, Tretinoin, Topical combination therapy, Inflammatory lesions, Non-inflammatory lesions, Global Acne Grading System
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Nishtar Medical UniversityUniversity, hospital or other
- Study start
- 17 Sep 2026 (actual)
- Primary completion
- 16 Mar 2027 (estimated)
- Study completion
- 16 Mar 2027 (estimated)
- First posted
- 4 Nov 2026 (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.
The purpose of this randomized controlled trial is to compare the effectiveness of two topical combination treatments for mild-to-moderate acne vulgaris: 1% nadifloxacin with 0.025% tretinoin cream versus 1% clindamycin with 0.025% tretinoin cream. The study will be conducted in the Department of Dermatology, Nishtar Hospital, Multan, and will enroll adults aged 18 to 40 years of either gender who are newly diagnosed with mild-to-moderate acne vulgaris. Participants with drug-induced acne, endocrine disorders (such as PCOS), other chronic facial skin conditions, pregnancy or lactation, chronic systemic illness, or known hypersensitivity to the study medications will be excluded.
Participants will be randomly assigned to one of two groups, with allocation concealed using sealed opaque envelopes. Group A will apply nadifloxacin plus tretinoin cream, and Group B will apply clindamycin plus tretinoin cream. In both groups, a thin layer of the assigned cream will be applied once daily at bedtime to the whole affected area after washing the face with a mild cleanser. Participants will also be advised to use a non-comedogenic moisturizer and sunscreen and to avoid other acne treatments. Follow-up visits will take place at 4, 8, and 12 weeks, with medication use checked by inspecting returned tubes and side effects (redness, dryness, peeling, burning, itching, allergic reactions) recorded at each visit.
At baseline and after 12 weeks of treatment, a consultant dermatologist who is unaware of the treatment assigned will count inflammatory, non-inflammatory, and total lesions and grade acne severity using the Global Acne Grading System. The main outcome is the reduction in the number of inflammatory lesions after 12 weeks. Secondary outcomes are the reduction in non-inflammatory and total lesions, change in acne severity grade, and side effects.
The study hypothesizes that the reduction in inflammatory lesions at 12 weeks is greater with nadifloxacin plus tretinoin than with clindamycin plus tretinoin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nadifloxacin 1% plus Tretinoin 0.025% Cream | Experimental | Drug: nadifloxacin, Drug: Tretinoin Cream 0.025%After washing the face with a mild cleanser and allowing the skin to dry for 20 to 30 minutes, a thin layer of 1% nadifloxacin combined with 0.025% tretinoin topical cream will be applied once daily at bedtime to the entire acne-affected area, avoiding the eyes, lips, and mucosal surfaces. Participants use a non-comedogenic moisturizer and sunscreen during the day and avoid other topical acne treatments. Treatment continues for 12 weeks |
| Clindamycin 1% plus Tretinoin 0.025% Cream | Active comparator | Drug: Tretinoin Cream 0.025%, Drug: ClindamycinAfter washing the face with a mild cleanser and allowing the skin to dry for 20 to 30 minutes, a thin layer of 1% clindamycin combined with 0.025% tretinoin topical cream will be applied once daily at bedtime to the entire acne-affected area, avoiding the eyes, lips, and mucosal surfaces. Participants use a non-comedogenic moisturizer and sunscreen during the day and avoid other topical acne treatments. Treatment continues for 12 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- newly diagnosed with acne vulgaris
- mild to moderate severity
Key exclusion criteria (6 listed)
- Drug induced acne or acneiform eruptions (corticosteroids, antiepileptics, lithium, iodides)
- endocrine disorders (PCOS, Cushing syndrome, congenital adrenal hyperplasia)
- chronic dermatological conditions affecting face (Rosacea, seborrheic dermatitis, perioral dermatitis)
- pregnant or lactating women
- chronic systemic illness (chronic liver disease, kidney disease)
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 |
|---|---|---|
| nadifloxacinTopical 1% nadifloxacin cream | Drug | Nadifloxacin 1% plus Tretinoin 0.025% Cream |
| Tretinoin Cream 0.025%Topical Tretinoin Cream 0.025% | Drug | Clindamycin 1% plus Tretinoin 0.025% Cream, Nadifloxacin 1% plus Tretinoin 0.025% Cream |
| ClindamycinTopical Clindamycin 1% cream | Drug | Clindamycin 1% plus Tretinoin 0.025% Cream |
Primary outcome
Reduction in number of inflammatory acne lesions
Time frame: From randomization to the end of treatment at 12 weeks
Change in the number of inflammatory lesions (papules, nodules, pustules), calculated as the difference between the baseline count and the count at 12 weeks. Lesions are counted by a consultant dermatologist blinded to the treatment assigned.
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 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Raheel T Associate Professor, FCPS study chair
Nishtar Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nadifloxacin, Tretinoin Cream 0.025% and Clindamycin in people with Acne Vulgaris, run by Nishtar Medical University at 1 site in Pakistan.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. 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 Pakistan. 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.
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?
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?
Contact Muhammad T Suleman, MBBS (+92 331 7291061, talha.cascade@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in number of inflammatory acne lesions (time frame: From randomization to the end of treatment at 12 weeks). 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 4 Nov 2026.