1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response - Data are available indefinitely at (Link to be included rmcbareilly@info.com).
   


6. For how long will this data be available start date provided 21-12-2021 and end date provided 21-12-2022?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Melasma is a common, subtle, symptomless, evenness, and patterned hyperpigmentation. It has predisposition for involvement of the cheeks, forearm, nose, upper lip, and forhead arises as asymmetrical shaped, but many of times it is markedly described, speckles of dark  to light brown pigmentation in the fair complexion or dark ones in dark complexion individuals. It may be idiopathic, may appear during pregnancy or be associated with use of oral contraceptives . It Affects almost  all the races, but it is more commonly seen in Hispanics and Asians with  skin types IV, V, and VI with centrofacial , malar, and mandibular distribution. ultraviolet (UV) radiation have some role in occurrence of melasma in case of non pregnant women and in men.1

It is most prevalent in Southeast Asia, in 40 % in females and 20% in males. In Asia, aesthetic consultation of melasma are 50% . Occurs in 50-70% of pregnant women in USA and in 50 to 80 % of Latina women. Despite the fact melasma is developed after pregnancy in 41% of females and spontaneous remission is found only in 8% of the cases.  In case of Prevalence it is on   side  in females with a male to female ratio of approximately 4:1. Women with multiple pregnancies have higher incidence (51%) compared with single women (25%) or with no pregnancy (24%).2

Based on the distribution of the facial lesions, melasma can be classified into three types, namely malar, centrofacial, and mandibular patterns. Melasma can be classified as epidermal, dermal, mixed, and indeterminate variants  on the basis of wood’s lamp examination.

  Treatment of melasma is tough because of its dermal constituent and propensity to recurrence. The most usual  therapy in treating melasma  is to use broad-spectrum (UVA & UVB) sunscreen , as is topical hydroquinone used very often . Retinoic acid (tretinoin) and azelaic acid are the  opposite lightening agents employed in melasma.To increase the efficacy while treating the melasma combination therapies such as tretinoin, azelaic acid , hydroquinone and steriods have been used  as compared with monotherapy. Kojic acid, isopropylhcatechol, N-acetyl-4-cysteaminylphenol, and flavonoid extracts are Other compounds that have been isopropylcatechol, N- acetyl-4- cysteaminylphenol .4

Different techniques like depigmenting agents ( Hydroquinone , kojic and azelaic acids,) and keratolytic agents (tretinoine, glycolic and trichloroacetic acids) are being used but chemical peeling provides more  rapid response than topical therapy. Chemical peels create injury at a specific skin depth and causes exfoliation that stimulates new epidermal growth and collagen with more even distribution of melanin .5

On histologic finding of melasma is increase melanin content in of both dermis and epidermis, but the quantity varies with the severity of hyperpigmentation. In, most of the studies manifest no quantifiable rise in melanocytes; however, the melanosomes are more copious and cells are enlarged with distinguished and broaden dendrites. In additional to color change other finding are solar elastosis and photoaging, expression of endothelial growth factors and increased mast cells in dermal blood vessels.6 

Diagnosis and evaluation of treatment of melasma can be made by clinical examination, photography, woods lamp examination, dermoscopy and confocal microscopy. The severity of melasma can be estimated using colorimetry, mexametry and calculation of melasma area severity index (MASI).7

Since very few clinical trials based on the comparative study of efficacy and tolerability of hydroquinone and kojic acid have been performed, the centre of this study is mostly on the effectivness of topical kojic acid and hydroquinone acid, so as to determine an effective modality of treatment for melasma. Moreover, previous studies mainly focused on multidrug therapy and not on monotherapeutic drug therapy which has less side effects and are sufficiently less costly and this study is based on monotherapeutic drug therapy.