A prospective observational study for evaluating drug prescribing pattern and effect of treatment on Quality of Life in acne vulgaris patients attending dermatology outpatient in tertiary care centre
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- 1-To analyse drug prescribing pattern in acne vulgaris patients in relation to severity of acne and prevailing treatment guidelines.
研究概览
简要总结
Acne is one of the most prevalent skin conditions observed in adolescent which remain continued even into adulthood. This chronic condition is associated with significant negative psychosocial impact, but it is frequently underestimated. Adult acne appears to have a greater impact on quality of life than acne in adolescents or younger adults. Limited Indian studies are there analysing prescription pattern, but no Indian study was found assessing change of Quality of life (QoL) with treatment while limited data is published from outside India. This study was designed to analyse drugs prescribing pattern, effect of drug therapy on Quality of Life (QoL) and adverse event profile in Acne vulgaris patients. This information is expected to be helpful in tailoring treatment approaches, providing appropriate counselling, and improving patient outcomes.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 15.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Newly enrolled Acne vulgaris patients seeking medical intervention for first time at AIIMS Rishikesh Age more than and equal to 15 years from either gender (male / female).
- •Patient willing to undergo treatment and follow ups.
- •Patient willing to give written informed consent to participate in study.
排除标准
- •Withdrawal of consent at any point after enrolment but before completion of follow-up.
- •Pregnant and Lactating women.
- •Patients diagnosed with systemic comorbidity/comorbidities requiring chronic treatment.
- •Any dermatologic disease other than acne vulgaris.
- •Patients with secondary causes of Acne like Drug induced Acne/acneiform eruptions.
结局指标
主要结局
1-To analyse drug prescribing pattern in acne vulgaris patients in relation to severity of acne and prevailing treatment guidelines.
时间窗: 1-At baseline visit | 2-at 0(baseline), 3, and 6 months
2-To assess effect of treatment on quality of life in acne vulgaris patients, using Dermatology Life Quality Index (DLQI) and acne- specific Cardiff Acne Disability Index (CADI) at multiple time points of therapy.
时间窗: 1-At baseline visit | 2-at 0(baseline), 3, and 6 months
次要结局
- To assess effect of treatment on self-esteem in acne vulgaris patients, using Rosenberg Self-esteem Scale (RSES) at multiple time points of therapy.(at 0(baseline), 3, and 6 months)
- To study the adverse event profile of treated acne vulgaris patients with active reporting of adverse events in patients treated with Retinoids.(During OPD visits (3, and 6 months) and through telephonic calls.)
研究者
Pramod Kumar
AIIMS Rishikesh