Assessing the Therapeutic effects of Topical Unani Compound Formulation for Treating Acne Vulgaris (Buthur-e-labaniyya): Randomized, Standard-Controlled Clinical Trial.

Acne vulgaris is a prevalent condition affecting the pilosebaceous unit, typicallyobserved in adolescents. The majority of acne cases manifest with a diverse range of lesions, including comedones, papules, pustules, and nodules, which can vary inseverity and extent. [1] Acne impacts almost all individuals aged 15 to 17 years, with moderate to severe cases observed in 15-20% of young individuals. The highest occurrence is typically seen between ages 15 to 20 across various ethnicities. Historical studies indicate a trend where males tend to experience more severe acne during late adolescence compared to females.[2]

Acne is characterized by four primary mechanisms: elevated sebum production, follicular hyper-keratinization, colonization by Propionibacterium acnes (P. acnes), and inflammatory responses.[3] A range of therapeutic options exists for treating acne, encompassing both topical and systemic modalities. Topical agents such as benzoyl peroxide, antibiotics, and retinoids are commonly used either individually or in combination to target various aspects of the condition, such as sebum production and inflammation. Systemic therapies, including oral antibiotics, hormonal treatments, and isotretinoin, are considered for more severe cases or when topical treatments prove inadequate. Physical treatments like lesion removal and phototherapy offer additional avenues for management.[3] However, it’s crucial to note that some therapies, particularly systemic retinoids like isotretinoin, carry significant risks, especially concerning teratogenicity, particularly when administered early in pregnancy. Potential foetal deformities associated with retinoid use include malformations of the central nervous system, craniofacial abnormalities, heart defects, and issues with the thymic or parathyroid glands. Therefore, it’s important to educate women of childbearing age about the importance of effective contraception when undergoing such treatments.[4] Topical medications, while effective in reducing severity and preventing scarring, can also lead to undesirable effects such as skin dryness, redness, burns, and potential recurrence of acne. [5]

According to Unani literature, Ibn Sina described in Al Qanoon that Buthur-elabaniyya is identified by tiny white eruptions appearing on the face, nose, and cheeks, resembling concentrated droplets of milk. [6] Basoor are of different types. These basoor are classified in various types depending upon the involvement of humours (dam, balgham, safra, sauda) or reeh. These basoor may be hot or cold in temperament. Har (Hot) swellings are caused by har khilt (matter) or due to sue mizaj of other khilt. Hot swellings are classified according to the nature of morbid material. Disturbance of khilt dam (blood) as phlegmonous (phalgamoni) and of the bilious humor as erythematous (hamrah), and

term their combinations as phlegmonous erythema (Phalgamonihamrah) and erythematous phlegmon (hamrahphalgamoni) according to the dominant humor. Other basoor which are not har are caused by Sauda, balgham (phlegm), fluid, and reeh.[7]

In the Unani medical tradition, a variety of single and compound drugs have been employed to address Busoor Labaniya. These medications are regarded as safe and generally devoid of significant side effects. Agents possessing detergent, resolving, blood-purifying, and desiccative properties have been utilized in the treatment of Busoor Labaniya.[8] The primary for conducting this study was to address the necessity for a safe and efficient medication. Therefore, the selection of this study aimed ‘‘to evaluate the safety and effectiveness of a topical Unani compound formulation in treating Acne Vulgaris (Buthur-e-labaniyya), through a randomized, standard-controlled clinicaltrial.’’