CDSCO panel gives nod for Phase III Clinical Trial of FDC Salicylic Acid Plus Luliconazole

However, this approval is subject to the condition that the firm should exclude the patient with an ear disorder from the study.

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CDSCO Panel
CDSCO Panel

Last Updated on January 26, 2023 by The Health Master

New Delhi: Drug major, Synokem Pharmaceutical has got approval from the Subject Expert Panel (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the proposed Phase III clinical trial of the fixed-dose combination (FDC), Salicylic acid IP plus Luliconazole IP (3%+1%) cream.

However, this approval is subject to the condition that the firm should exclude the patient with an ear disorder from the study.

In addition, the committee opined the firm that Autoimmune deficiency syndrome term should be elaborated or corrected and the product should not be applied on delicate areas of skin, flexures and near to eyes.

This came after the firm presented its proposal along with Phase III clinical trial protocol before the committee for Salicylic acid IP Luliconazole IP (3%+1%) cream.

Use of Salicylic Acid

Salicylic acid topical, depending on the dosage form and strength of the preparation, is used to treat many skin disorders, such as:

  • Acne,
  • Dandruff,
  • Psoriasis,
  • Seborrheic dermatitis of the skin and scalp,
  • Calluses,
  • Corns,
  • Common warts,
  • Plantar warts.

Salicylic acid works to treat acne by unclogging blocked pores.

It does this by breaking down the bonds between dead skin cells so that they can release from the pore more easily, and by breaking down oils, such as sebum. Salicylic acid also decreases the skin’s sebum production, leading to fewer breakouts.

Use of Luliconazole

Luliconazole is an antifungal medication that treats:

  • Skin infections.
  • It works by killing the fungi on the skin by destroying their cell membrane.
  • Luliconazole topical cream is used to treat infections caused by a fungus or yeast.

It works by killing the fungus or yeast or preventing its growth. Luliconazole cream is used to treat:

  • Ringworm of the body (tinea corporis).
  • Luliconazole is an antifungal that belongs to the azole class.

Although the exact mechanism of action against dermatophytes is unknown, luliconazole appears to inhibit ergosterol synthesis by inhibiting the enzyme lanosterol demethylase.

At the recent SEC meeting for Dermatology and Allergy held on the 12th of January 2022, the expert panel reviewed the proposal along with the Phase III clinical trial protocol of the fixed drug combination salicylic acid IP plus luliconazole IP(3%+1%) cream.

After detailed deliberation, the committee recommended the grant of permission to conduct the proposed Phase III Clinical trial with the following conditions:

  • 1. Patients with ear disorders should be excluded from the study.
  • 2. Autoimmune deficiency syndrome terms should be elaborated on or corrected.
  • 3. Product should not be applied on delicate areas of skin, flexures and near to eyes.

Forms: Clinical Trial

Schedules: Clinical Trials

Notifications: New Drugs, FDC, Clinical Trial  

Other details about New Drugs, FDCs, Clinical trial    

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