NCT07915648 Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
| NCT ID | NCT07915648 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Nishtar Medical University |
| Condition | Acne Vulgaris |
| Study Type | INTERVENTIONAL |
| Enrollment | 158 participants |
| Start Date | 2026-09-17 |
| Primary Completion | 2027-03-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 158 participants in total. It began in 2026-09-17 with a primary completion date of 2027-03-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * newly diagnosed with acne vulgaris * mild to moderate severity Exclusion Criteria: * 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
Contact & Investigator
Raheel T Associate Professor, FCPS
STUDY CHAIR
Nishtar Medical University
Frequently Asked Questions
Who can join the NCT07915648 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Acne Vulgaris. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07915648 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07915648 currently recruiting?
Yes, NCT07915648 is actively recruiting participants. Contact the research team at talha.cascade@gmail.com for enrollment information.
Where is the NCT07915648 trial being conducted?
This trial is being conducted at Multan, Pakistan.
Who is sponsoring the NCT07915648 clinical trial?
NCT07915648 is sponsored by Nishtar Medical University. The principal investigator is Raheel T Associate Professor, FCPS at Nishtar Medical University. The trial plans to enroll 158 participants.