A Phase 4 interventional study of nadifloxacin and Tretinoin Cream 0.025% in Acne Vulgaris, sponsored by Nishtar Medical University. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Nishtar Medical University · Phase 4, Interventional, and Treatment
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.
790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.
This study's planned enrollment of 158 is above the median of 70 across 672 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Nishtar Medical University is the lead sponsor of 29 studies on the registry; 9 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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% 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
Drug: Tretinoin Cream 0.025% · Drug: Clindamycin
Topical 1% nadifloxacin cream
Topical Tretinoin Cream 0.025%
Topical Clindamycin 1% cream
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.
Time frame: From randomization to the end of treatment at 12 weeks
Reduction in number of non-inflammatory acne lesions
Change in the number of non-inflammatory lesions (open and closed comedones), calculated as the difference between the baseline count and the count at 12 weeks, assessed by a blinded consultant dermatologist.
Time frame: From randomization to the end of treatment at 12 weeks
Reduction in total acne lesion count
Change in the total number of inflammatory and non-inflammatory lesions, calculated as the difference between the baseline count and the count at 12 weeks, assessed by a blinded consultant dermatologist.
Time frame: From randomization to the end of treatment at 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Mar 2027, 5 months after the start.
Of 44 phase 4 interventional studies under Acne Vulgaris, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 16. This study's planned 5 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Nishtar Medical University