Clinical trial NCT04118296: Decreasing Severity of Acne Vulgaris After the Use of a Combination of Anti-Acne Cream
Official title: Decreasing Severity of Acne Vulgaris After the Use of a Combination of Anti-Acne Cream in West Jakarta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Sukma Skin Treatment
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 150
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This research is a clinical trial research with an experimental research design. Epidemiological association analysis is obtained by calculating Relative Risk (RR) because the research use experimental design and the nature of the two variables studied is categorical.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Knowing the relationship & possibility between the use of a combination of anti-acne cream with a decrease in the severity of acne vulgaris
timeFrame: The severity of acne vulgaris is measured after 1 month of use of the combination of anti-acne cream
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: SMKN 35 Jakarta Barat
state: DKI Jakarta
Study officials:
References:
citation: Perkins AC, Cheng CE, Hillebrand GG, Miyamoto K, Kimball AB. Comparison of the epidemiology of acne vulgaris among Caucasian, Asian, Continental Indian and African American women. J Eur Acad Dermatol Venereol. 2011 Sep;25(9):1054-60. doi: 10.1111/j.1468-3083.2010.03919.x. Epub 2010 Nov 25.
citation: Ray C, Trivedi P, Sharma V. Acne and Its Treatment Lines. International Journal of Research in Pharmaceutical and Biosciences. 2013 January 23; 3(1): p. 1-16
citation: Cunliffe W, Gollnick H. Topical Theraphy. In Cunliffe WJ GH. Acne Diagnosis and Management. London: Martin Dunitz Ltd; 2001. p. 107-114.
citation: Katsambas A, Dessinioti C. New and emerging treatments in dermatology: acne. Dermatol Ther. 2008 Mar-Apr;21(2):86-95. doi: 10.1111/j.1529-8019.2008.00175.x.
citation: Rathi SK. Acne vulgaris treatment : the current scenario. Indian J Dermatol. 2011 Jan;56(1):7-13. doi: 10.4103/0019-5154.77543.