None listed
Conditions
Interventions
Intervention1: Besifloxacin Hydrochloride
topical gel (2%): Besifloxacin Hydrochloride
topical(facial) gel (2%) 1 gram
to be applied twice daily(BD)for
12 weeks. Each tube is of 45
grams
Control Inter
Sponsors
Dr Rohit Batra
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subject is willing and able to give written informed consent. 2.Healthy male or non-pregnant female aged � 18 and � 80 years. 3.Clinical diagnosis of suspected Acute GNF with papules, pustules and peri nasal and/or peri oral involvement. 4.Microbiological analysis confirming presence of gram-negative bacteria (Microbiology analysis report will be available approximately 72 hours from sample collection. Report is not required for screening or starting treatment.) 5. Actively cooperating to participate in the trial, to follow the instructions of the Investigator and to attend the agreed visits.
Exclusion criteria
Exclusion criteria: 1.Presence of skin lesions, e.g. open wounds or ulcers in the respective skin areas. 2.Presence of skin diseases other than acute folliculitis and acne interfering with study treatment. 3.Treatment with epidermal growth factor receptor (EGFR) inhibitors. 4.Topical or systemic use of any dermatological product (e.g. medications, medicinal products, cosmetic products) on the trial areas during the trial. 5.Any systemic or topical immunosuppressive therapy (e.g. corticosteroids) within 3 weeks prior to randomization. 6.Congenital or acquired immunodeficiency. 7.Participation in any other trial within 30 days prior to randomization or during the trial. 8.Contraindications to any component of the study medication. 9.History of drug, alcohol, or chemical abuse. 10.Females of childbearing potential may not be recruited if they are not willing to use of effective method for contraception throughout the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with positive clinical response measured with investigatorââ?¬â?¢s assessment scale (Annexure-I) at day 7/14.Timepoint: Day 0,Day 7/14. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with positive clinical response measured with investigatorââ?¬â?¢s assessment scale (Annexure-I) at day 7/day 14. Percentage of subjects with at least a 2 points positive change in the visual analogue scale (VAS) from baseline. (Annexure-II). Percentage improvement in the visual analogue scale (VAS) from baseline. (Annexure-II). Timepoint: Day 0,Day 7/14 | — |
Countries
India
Contacts
Public ContactDr Rohit Batra
Derma World Skin and Hair Clinc
Outcome results
None listed