Skip to main content
OpenTrials
Completed

NCT Number: NCT04118296

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

SMKN 35 Jakarta Barat

Jakarta, DKI Jakarta, 11140, Indonesia

About this study

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.

We researchers always uphold the investigator's ethics and professionalism while conducting this research, and do not fight the medical oath we have taken.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Anti-Acne Preparations for Topical Use

Drug

Combination of anti acne cream that contain active substances such as Clindamycin 3%, Dexamethasone 0.05% and Tretinoin 0.05%

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sukma Skin Treatment

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 8, 2019
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.