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

NCT04118296 | Completed Phase 1

• 1 other identifier: SST-02-2019
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Outcome Measures

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

  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.

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

Study Arms (1)

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%

Drug: Anti-Acne Preparations for Topical Use

Interventions

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%

Intervention

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sukma Skin Treatment: lead

Study Sites (1)

SMKN 35 Jakarta Barat

Jakarta, DKI Jakarta, 11140, Indonesia

Location

Related Publications (5)

• 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.

  PMID: 21108671 RESULT

• 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

  RESULT

• Cunliffe W, Gollnick H. Topical Theraphy. In Cunliffe WJ GH. Acne Diagnosis and Management. London: Martin Dunitz Ltd; 2001. p. 107-114.

  RESULT

• 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.

  PMID: 18394082 RESULT

• Rathi SK. Acne vulgaris treatment : the current scenario. Indian J Dermatol. 2011 Jan;56(1):7-13. doi: 10.4103/0019-5154.77543.

  PMID: 21572783 RESULT

Related Links

• Acne Vulgaris
• Clindamycin Topical

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Researcher

Model Details: 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.

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 8, 2019
• Study Start: October 8, 2019
• Primary Completion: November 6, 2019
• Study Completion: November 30, 2019
• Last Updated: June 4, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)