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临床试验/NCT04118296
NCT04118296已完成1 期

Decreasing Severity of Acne Vulgaris After the Use of a Combination of Anti-Acne Cream in West Jakarta

Sukma Skin Treatment1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年10月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Knowing the relationship & possibility between the use of a combination of anti-acne cream with a decrease in the severity of acne vulgaris

研究概览

简要总结

This study was conducted to see whether there was a decrease in the degree of acne vulgaris / pimple, to find out what proportion of respondents experienced a decrease in severity and who did not experience a decrease in the severity of acne vulgaris after the use of an anti-acne cream combination containing active ingredients such as; Tretinoin 0.05% (derivatives of Vitamin A), Clindamycin 5% (antibiotics), and Dexamethasone 0.05% (anti-inflammatory) for 1 month of use.

详细描述

This research was conducted based on the results of epidemiological studies that the group of adolescents aged 14-19 years had a fairly high prevalence of acne vulgaris, which amounted to 83-85% for female, 95-100% for male and this prevalence rate was increasing over the years. Acne vulgaris is not a dangerous disease, but has a large enough impact for sufferers, especially teenagers. Physical and psychological effects can cause anxiety, depression, and reduce the confidence of sufferers.

Many drugs for acne vulgaris are sold freely and can be bought by everyone without the need to consult a doctor first, coupled with the lack of knowledge of adolescent groups about acne vulgaris and its treatment options, this causes the lack of accurate acne treatment and increases the risk of effects side of the drug. The use of topical medicines in the form of a combination of anti-acne cream is one of the best choices because all the components needed to deal with acne can be combined to become one so that it is more effective and efficient

The short-term goal of this research is to find out what proportion of respondents with mild, moderate and severe acne before being given an intervention in the form of using a combination of anti-acne cream, the proportion of respondents with mild, moderate and severe acne after being given an intervention, the proportion of respondents who were given intervention and experienced decrease the severity of acne vulgaris, and find out the relationship between the use of a combination of anti-acne cream with a decrease in the severity of acne vulgaris.

This research is an experimental design clinical trial research. The research hypothesis is that the use of a combination of anti-acne creams can reduce the severity of acne vulgaris. The study population and sample were in the form of a group of adolescents aged 14-19 years, located in the sampling area, and met the inclusion criteria. The number of samples is 186 respondents .

The ingredients contained in the combination of anti-acne creams are commonly used ingredients and are one of the first-line treatments for acne vulgaris, namely Tretinoin 0.05% (Vitamin A derivatives), Clindamycin 3% (antibiotics), and Dexamethasone 0.05% (anti-inflammation). Based on the literature it is known that these three active substances have proven to be effective in treating acne vulgaris. Side effects can occur mild and not like irritation, skin peeling, redness, and local allergic reactions. These side effects can be minimized by using according to doctor's instructions and will disappear if the use of the cream is stopped.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • respondents aged 14-19 years
  • suffering from mild, moderate or severe degree of acne vulgaris in the face area regardless of the respondent's skin type
  • agreed to informed consent
  • agreed to use a combination of anti-acne creams only and stopped all other skin treatments on the face for at least 3 days

排除标准

  • respondents with other skin diseases on the face such as atopic dermatitis, contact, rosacea, viral infections, impetigo, fungal infections, acne eruption
  • respondents who are suspected of having allergies to active substances contained in a combination of anti-acne creams

研究组 & 干预措施

Intervention

Experimental

Intervention will be given in the form of the use of anti-acne combination creams that contain active substances such as Clindamycin 3%, Dexamethasone 0.05% and Tretinoin 0.05%

干预措施: Anti-Acne Preparations for Topical Use (Drug)

结局指标

主要结局

Knowing the relationship & possibility between the use of a combination of anti-acne cream with a decrease in the severity of acne vulgaris

时间窗: The severity of acne vulgaris is measured after 1 month of use of the combination of anti-acne cream

Epidemiological association analysis is obtained by calculating Relative Risk (RR). If RR = 1, it means that the probability of a severe degree of acne vulgaris with a moderate degree of acne vulgaris is the same as the degree of acne reduction. If RR\> 1, it means that the possibility of severe acne vulgaris group with moderate acne vulgaris is greater for a decrease in acne degree. If RR \<1, it means that the possibility of severe acne vulgaris group with moderate acne vulgaris is smaller to experience a decrease in acne degree.

次要结局

未报告次要终点

研究者

发起方
Sukma Skin Treatment
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessica Elizabeth

Co-Researcher

Sukma Skin Treatment

研究点 (1)

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