Subject: Participation in surveillance “Assessment of drug utilization pattern of anti-acne medications in Indian patients with acne vulgaris”
Acne vulgaris is the most common skin disease, affecting between 70 and 80% of adolescents and young adults. Acne is estimated to affect 9.4% of the global population, making it the eighth most prevalent disease worldwide.
The pathogenesis of acne is complex and not fully understood, but involves many factors that influence the pilosebaceous glands including androgen-stimulated sebaceous gland hyperplasia and seborrhea, altered follicular growth and differentiation leading to hyperkeratinization and the precursor lesion (the microcomedone), Propionibacterium acnes colonization, inflammation, and immune response.
The spectrum of acne lesions ranges from non-inflammatory open or closed comedones (blackheads and whiteheads) to inflammatory lesions, which may be papules, pustules, or nodules.
Acne treatments are available both over the counter and by prescription. Prescription medications are available in topical and oral forms. Topical medications that are approved include benzoyl peroxide, salicylic acid, antibiotics, retinoids, combination products (benzoyl peroxide, retinoid, and antibiotic) and azelaic acid. Topical therapy may be used alone or in combination with oral therapeutic agents. Systemic therapy includes antibiotics, antiandrogens, and isotretinoin. Monotherapy is usually only appropriate for mild acne; more severe acne often requires a combination of agents with different mechanisms to have a meaningful effect on acne.
There is a lack of recent real-world evidence on use of anti-acne medications in patients with acne vulgaris in India.
This retrospective, cross-sectional multicenter surveillance is planned to evaluate the drug utilization pattern of anti-acne medications in patients with acne vulgaris in India.
We invite you to participate in this surveillance. On acceptance, you will need to capture the relevant data as mentioned in the standard Data Collection Form (DCF) provided, from the patient’s medical records (case papers and investigational reports – hereafter referred as source documents).
We would recommend you to capture data fulfilling the criteria as outlined in the protocol.
We wish to inform you that the DCF will capture all data in de-identified form and any identifiable parameters which may potentially disclose the identity of the patient such as name or address will strictly not be captured so as to ensure we maintain patient confidentiality. We would encourage you to carefully fill all available information to the fullest as recommended in the DCF.
In alignment with good clinical research practices, an independent CRO may monitor this surveillance and do the source data verification of the data captured in the DCF with copies of the patients’ source medical records (case papers and investigational reports) to ensure that the data entered in the DCFs are accurate and in alignment with the patients’ medical records.
If you agree to participate in the said surveillance, we would request you to sign and return the enclosed reply along with your visiting card for accuracy of records.
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