Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
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.
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Muhammad T Suleman, MBBS
- Número de teléfono: +92 331 7291061
- Correo electrónico: talha.cascade@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Raheel T Associate Professor, FCPS
- Número de teléfono: +92 300 6332846
- Correo electrónico: raheeldermatology1231@gmail.com
Ubicaciones de estudio
-
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Punjab Province
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Multan, Punjab Province, Pakistán, 60000
- Reclutamiento
- Nishtar Medical University and Hospital
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Contacto:
- Muhammad T Suleman, MBBS
- Número de teléfono: +92 331 7291061
- Correo electrónico: talha.cascade@gmail.com
-
Contacto:
- Raheel T Associate Professor, FCPS
- Número de teléfono: +92 300 6332846
- Correo electrónico: raheeldermatology1231@gmail.com
-
Investigador principal:
- Muhammad T Suleman, MBBS
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Nadifloxacin 1% plus Tretinoin 0.025% Cream
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 |
Topical 1% nadifloxacin cream Topical Tretinoin Cream 0.025% |
|
Comparador activo: Clindamycin 1% plus Tretinoin 0.025% Cream
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 |
Topical Tretinoin Cream 0.025% Topical Clindamycin 1% cream |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reduction in number of inflammatory acne lesions
Periodo de tiempo: 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. |
From randomization to the end of treatment at 12 weeks
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reduction in number of non-inflammatory acne lesions
Periodo de tiempo: From randomization to the end of treatment at 12 weeks
|
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. |
From randomization to the end of treatment at 12 weeks
|
|
Reduction in total acne lesion count
Periodo de tiempo: From randomization to the end of treatment at 12 weeks
|
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. |
From randomization to the end of treatment at 12 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Raheel T Associate Professor, FCPS, Nishtar Medical University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- U1111-1348-8715
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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