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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
Anti-Acne Preparations for Topical Use
Sponsored by
Sukma Skin Treatment
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SMKN 35 Jakarta Barat

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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%

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 3, 2019
Last Updated
May 31, 2020
Sponsor
Sukma Skin Treatment
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1. Study Identification

Unique Protocol Identification Number
NCT04118296
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 8, 2019 (Actual)
Primary Completion Date
November 6, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sukma Skin Treatment

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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%
Intervention Type
Drug
Intervention Name(s)
Anti-Acne Preparations for Topical Use
Intervention Description
Combination of anti acne cream that contain active substances such as Clindamycin 3%, Dexamethasone 0.05% and Tretinoin 0.05%
Primary Outcome Measure Information:
Title
Knowing the relationship & possibility between the use of a combination of anti-acne cream with a decrease in the severity of acne vulgaris
Description
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.
Time Frame
The severity of acne vulgaris is measured after 1 month of use of the combination of anti-acne cream

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
SMKN 35 Jakarta Barat
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
11140
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Because the respondent's personal data is confidential and it's written in the informed consent that the researcher will not share the respondent's personal data
Citations:
PubMed Identifier
21108671
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.
Results Reference
result
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
Results Reference
result
Citation
Cunliffe W, Gollnick H. Topical Theraphy. In Cunliffe WJ GH. Acne Diagnosis and Management. London: Martin Dunitz Ltd; 2001. p. 107-114.
Results Reference
result
PubMed Identifier
18394082
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.
Results Reference
result
PubMed Identifier
21572783
Citation
Rathi SK. Acne vulgaris treatment : the current scenario. Indian J Dermatol. 2011 Jan;56(1):7-13. doi: 10.4103/0019-5154.77543.
Results Reference
result
Links:
URL
https://emedicine.medscape.com/article/1069804-overview#a6
Description
Acne Vulgaris
URL
https://medlineplus.gov/druginfo/meds/a609005.html
Description
Clindamycin Topical

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

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