Healthy volunteer study. The product under development will be used for the treatment of acne vulgaris.
Conditions
Interventions
Product Name: 1% Tert-butylhydroquinone
Product Code: TBHQ
Pharmaceutical Form: Gel
INN or Proposed INN: Tert-butylhydroquinone
CAS Number: 1948-33-0
Concentration unit: % (W/W) percent weight/weight
Sponsors
Syntopix Group plc
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Male - age 16 - 50 years - in good health - Caucasian Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - any skin disease affecting the upper back - history of allergy or suspected allergy to any of the test substances - taking any regular treatment via the systemic route - use of any topical skin care preparations on the back or anti-bacterial skin care preparations at any site - atopy - any chronic medical condition that oculd affect drug handling by the skin, liver or kidneys - positive result in abbreviated drug screen - unwilling or unable to attend appointments on 15 consecutive days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the ability of : - Topical formulations of 1% TBHQ, 1%ZnP and 1% BPO - A combination of 1% TBHQ and 1% BPO applied from separate topical formulations to reduce the population density (viable count) of cutaneous propionibacteria on the upper back by >/= 90% within 14 days and to determine the length of time it takes to achieve this .;Secondary Objective: 1. To assess the safety and tolerability of: - topical formulations of 1% TBHQ, 1% ZnP and 1% BPO - a combination of 1% TBHQ and 1% BPO applied from separate topical formulations 2. To assess the effect of these same topical formulations on the population density (viable count) of coagulase-negative staphylococci on the upper back;Primary end point(s): A >/= 90% mean reduction in propionibacterial population density on the upper back within 14 days from the start of treatment | — |
Countries
United Kingdom
Outcome results
None listed