Clinical studies for dandruff treatments to determine product efficacy and tolerability, incorporating experienced Investigators, scalp sampling and bioanalysis
Dandruff clinical studies assess the effectiveness of a dandruff shampoo or treatment for reducing the severity of dandruff for a consumer. Dandruff is a commonly experienced condition by both men and women. It is non-inflammatory in nature but is often a source of distress. The real cause for dandruff formation is yet to be fully understood however, some common factors, which often play a role in the development of dandruff, include fungal infection, sebum (oil) secretions, hormonal changes, insufficient rinsing and brushing of the hair, use of certain cosmetic products and stress. The incidences of dandruff can be more common and more severe during the winter season and so, if possible, clinical trials should be run in the colder months of the year, to make the recruitment phase more efficient.
Antidandruff shampoo can only be classed as effective if it significantly and consistently reduces the dandruff levels attained after shampooing and so accurate assessment, precise timing of observations and measurement is required over a suitable time period.
Clinical trials require effective recruitment and cooperation of the study participants. Recruitment of subjects for dandruff studies can be difficult. It is typical to recruit at least moderate to severe sufferers, though it is also desirable to have some subjects who are only slightly affected when investigating the safety profile of new products.
Dandruff Clinical Trials Experience
Intertek has considerable experience with conducting dandruff clinical studies to determine the efficacy and safety of novel treatments such as shampoos developed to address moderate to severe scalp Dandruff or Seborrheic Dermatitis (pityriasis capitis). Our team can run placebo-controlled studies determining the safety and efficacy of treatments from our clinical study centre in Paris, France.
Our examiners and dermatologist are experienced in visual scalp assessment and dandruff severity, working to relevant end-points such as severity scores (TSS) (sum of erythema, scaling and pruritus), Investigator’s Global Assessment scale, scalp area, redness/erythema, papules/pustules, excoriation, crusts/scars and blemishes, itching and flaking skin, which are associated with severe dandruff conditions.
Dandruff Clinical Trials Participant Recruitment
Our recruitment solutions can be tailored to your study’s needs. Our participant database is one of the largest in the industry. We are able to select participants based on age, gender and brand loyalty. We can provide panels with specific consumer profiles based on consumer preferences, habits and attitudes, hair or scalp conditions.
Dandruff Instrumental Evaluation and Bioanalysis
Intertek’s examiners utilise multiple measurement techniques to evaluate dandruff during clinical trials. These include the Biox Aquaflux which allows assessment of the transepidermal water-loss (TEWL), Dermalab pin probe which measures skin hydration, the Courage & Khazaka Sebumeter which records sebum measurement. These are complemented by controlled clinical photography.
Our Good Clinical Practice (GCP) and Good laboratory Practice (GLP) compliant systems allow skin sampling techniques from the scalp including buffer washes, tape stripping / D-squame sampling and biopsies and bioanalysis of these tissues using bioanalytical techniques (LC-MS or GC-MS or ICP-MS) or tissue microscopy (optical, TEM or SEM). Through established research partners, Intertek also provides supporting microbiology services to complement clinical trials.
Dandruff Consumer Perception Studies
Through investigator and subject-assessed efficacy studies, we collect consumer perception information such as subject satisfaction consumer acceptability, habits and attitudes, performance, consumer preferences, self-confidence and attractiveness. Our information helps clinicians to determine treatment options for dandruff or other scalp conditions which also provide a high level of patient acceptance. The information also helps manufacturers to make decisions during product development.
Patient self-assessment can include quality of life, perception of improvement in dandruff severity and the urge to itch.
We are one of the world’s largest CROs for the provision of consumer trials of hair and scalp products, offering Total Quality Assurance with expertise in the recruitment and management of studies to provide robust data to support your product development, marketing claims, defense against legal challenges and product launches.