Subject:Participation in surveillance “Assessment of utilization pattern of sunscreens in Indian patients with facial hyperpigmentation”
In India, pigmentation disorders cause psychosocial effects that can lead to repercussions on the quality of life. The common presentations were hyperpigmentation, melasma, indistinct pigmented macules and periorbital hyperpigmentation. The most common
clinical diagnosis of facial melanoses is Melasma (chloasma). Management of melasma and similar pigmentary ailments is complex due to heterogenous nature of these conditions. However, protection from sunlight and depigmentation (skin lightening or brightening) is the first step towards a practical treatment approach. The current treatment option includes photoprotection by using sunscreen, topical compounds (like skin lightening/brightening agents), amouflage, bleaching agents, chemical peels, and laser and light therapies depending on skin type and condition. There are two known types of sunscreens depending on one of two mechanisms: Ultraviolet (UV) blocking and UV absorbing. UV-blocking agents typically contain titanium dioxide and zinc dioxide, which provide physical filtering against UV light and tend to be chalky in consistency. UVabsorbing agents (e.g. Tinosorb S), on the other hand, are chemical agents commonly found in an aqueous base. For at-risk patients, the recommendation is to use a broadspectrum photo protecting agent with UVB and UVA filter (sun protection factor 30–50 and protective clothing when exposed to the sun).
There is a lack of recent real-world evidence on use of sunscreens in patients with facial hyperpigmentation in India.
This retrospective, cross-sectional multicenter surveillance is planned to evaluate the utilization pattern of sunscreens in patients with facial hyperpigmentation 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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