Clinical trials for Acne Treatments to meet the requirements of regulatory authorities for pharmaceutical safety and efficacy studies
Clinical trials for acne (acne vulgaris) treatments are vital to investigating the efficacy and safety and long term safety of topical acne medications. Acne is a chronic disease of sebaceous follicles. It is experienced by up to 90% of people during adolescence, with varying severity and with some patients suffering into middle age. Factors which play a role in the development of spots are among others, sebum production, hormones and hereditary bacterial colonisation of the skin. Although acne vulgaris affects both genders, severity may be greater in male patients. Acne varies in severity as evidenced by lesion type, size, numbers, scarring, and post- 50 inflammatory pigmentary changes.
It is important that all drug products for acne be evaluated for safety and efficacy in the treatment of facial acne. Regulatory authorities require demonstration of safety and efficacy of the investigational drug in at least two adequate and well-controlled clinical studies.
Our dermatologists conduct investigator site studies to determine if a new acne treatment is safe and effective at reducing facial acne using co-primary endpoints that evaluate an Investigator’s Global Assessment (IGA) scale and acne lesion counts.
We can provide investigator site services including planning, patient recruitment clinical protocol design, dermatological assessment, collection of relevant data and reporting to meet your objectives. To meet regulatory authorities recommendations we can run randomized, blinded, multi-center studies with suitable comparator arms, which usually include a vehicle or placebo control.
With strengths in the safety assessment of topically applied treatments our investigator sites design and conduct studies working to the EU Directive 2001/20/EC (Clinical Trials Directive), the EU Directive 2005/28/EC (GCP Directive), The Medicines for Human Use (Clinical Trial) Regulations 2004 and its subsequent amendments and also the ISO 14155 Clinical Investigation of Medical Devices guidelines.
Acne Visual Clinical Assessment
Our clinical team have experience across the full range of visual acne assessment for we efficacy including facial lesion count and size, assessment of inflamed lesions (papules & pustules) and non-inflamed lesions (blackheads & whiteheads) and by the Investigator’s Global Assessment (IGA) scale of acne severity. Additionally we can include Dermal Irritancy scoring and tolerance assessment. To achieve precision our clinicians are highly trained in the counting of lesions for acne vulgaris and by combining the two approaches of ordinal global assessment scale and lesion count assessments we ensure a balanced approach toward the evaluation of acne severity.
Acne Study Recruitment Solutions
Our database of pre-qualified study participants includes an age range from pre-teen to middle age and examiners with experience of the assessment of acne. At Intertek we have expertise in several measurement techniques.
Complementary Acne Assessment Techniques
Our dermatology studies can also include the use of instrumentation to assist assessment of efficacy such as the Courage & Khazaka Sebumeter which can reproducibly and accurately determine the sebum level of the skin surface. We use controlled, reproducible photography for image capture and analysis and quantitative sampling of cutaneous microflora on skin. Through a number of established research partners, we are also able to provide supporting microbiology services to complement the clinical trial. Quality of Life Questionnaires drives complementary information to support your clinical investigation.
Our dermatology clinical trial experience for acne treatments ensures that you will benefit from rapid, highly credible clinical trial data that will support your decision making process and accelerate your product development.