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

M

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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