CTRI/2024/04/065630尚未招募2 期
Efficacy of Khadiratriphaladi Kwatha Ghana (capsule) andShalmali gel in the management of Yuvanpidika (Acne vulgaris) in Adolescents -A Randomized Placebo Controlled Clinical Trial - NI
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Adolescents aged between 10-16 years of either gender having classical features of Yuvanpidika.
- •2.Adolescent has an Investigator’s Global Assessment (IGA) score of 2-3 [0 (clear) to 4 (severe) scale]. (Mild to moderate cases of facial Acne vulgaris)
- •3.Adolescents/ Parents willing to give written informed assent/ consent.
- •4.Adolescents and parent/guardian (if applicable) are willing to comply with study instructions and return to the OPD for required visits.
排除标准
- •1.Adolescents having any other skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.
- •2.Adolescents having nodulocystic acne.
- •3.Adolescents having any systemic diseases and auto immune disorder.
- •4.Adolescents currently enrolled in an investigational drug or device study.
- •5.Adolescents who have received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (Baseline).
- •6.Adolescents having known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles
- •7.Adolescents and parent/guardian (if applicable) are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
- •8.Adolescent has used any of the following topical anti-acne preparations or procedures on the face:
- •a.Topical anti-acne treatments including, but not limited to, over-the-counter (OTC) acne cleansers or treatments, benzoyl peroxide, antibiotics, azelaic acid, sulfa based products, corticosteroids and salicylic acid within two (2) weeks of the initiation of treatment.
- •b.Retinoids, including tazarotene, adapalene, tretinoin, within four (4) weeks of the initiation of treatment.
- •c.Light treatments, microdermabrasion, or chemical peels within eight (8) weeks of the initiation of treatment.
- •9.Adolescent has used the following systemic anti-acne medications:
- •a.Corticosteroids (including intramuscular and intralesional injections) within four (4) weeks of the initiation of treatment. Inhaled, intranasal or ocular corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least four (4) weeks prior to the initiation of treatment).
- •b.Antibiotics within four (4) weeks of the initiation of treatment with the exception of five (5) days or less of antibiotic therapy during this period, BUT with no antibiotics use permitted within one (1) week prior to the initiation of treatment.
- •c.Spironolactone within eight (8) weeks of the initiation of treatment with the exception of five (5) days or less of spironolactone therapy during this period, BUT with no spironolactone use permitted within one (1) week prior to the initiation of treatment.
- •d.Retinoid therapy within six (6) months of the initiation of treatment
- •e.Other systemic therapy which may materially affect the subject’s acne in the opinion of the investigator.
研究者
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