Comparison of Nadifloxacin Cream Alone and With Benzoyl Peroxide Solution in the Treatment of Acne

Marmara University

Status and phase: Unknown; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: benzoyl peroxide; Drug: nadifloxacine

Study type: Interventional

Funder types: Other

Identifiers

NCT00869492

mar-der1

dermatology1

Details and patient eligibility

About

The purpose of this study is to determine whether using of nadifloxacine 1% cream and benzoyl peroxide 5% solution together is more effective than using nadifloxacine alone in the treatment of mild to moderate facial acne.

Full description

Nadifloxacin; a new topical antibiotic for the treatment of acne has recently been marketed in our country. Only a few studies on its use and effectiviness could be found in the literature. Nadifloxacin may be an alternative to other topical antibiotics and benzoyl peroxide or its use along with benzoyl peroxide may be more effective and rational to prevent possible future resistance.

Enrollment: 90 estimated patients

Sex: All

Ages: 14 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of mild to moderate facial acne vulgaris
• Must have at least 10 inflammatory and/or non-inflammatory and no more than 3 nodulocystic acne lesions

Exclusion criteria

• Nodulocystic acne lesions more than 3 and pure comedonal acne
• Additional truncal acne needs systemic therapy
• Usage of topical treatments for acne in last 2 weeks, systemic antibiotic in last 4 weeks, systemic isotretinoin in last 6 months
• Application of chemical peels and laser in last 4 weeks
• Usage of hormones in last 3 months
• Clinical signs of hyperandrogenism in females
• Pregrancy and lactation
• Hypersensitivity to interventions
• Additional facial skin diseases (eg. atopic and seborreic dermatitis)
• Photosensitive disorders and usage of drugs which can trigger Photosensitive conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

90 participants in 2 patient groups

A

Other group

Description:

instructed nadifloxacine 1% cream twice dailly, and placebo for benzoyl peroxide 5% solution once dailly

Treatment:

Drug: nadifloxacine

B

Other group

Description:

instructed nadifloxacine 1% cream twice dailly, and active benzoyl peroxide 5% solution once dailly

Treatment:

Drug: nadifloxacine

Drug: benzoyl peroxide