Acne VulgarisPhase 1/2NCT04118296
Decreasing Severity of Acne Vulgaris After the Use of a Combination of Anti-Acne Cream
A Phase 1/2 study testing Anti-Acne Preparations for Topical Use in people with Acne Vulgaris, run by Sukma Skin Treatment at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Anti-Acne Preparations for Topical Use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIndonesia
- Study dates
- 8 Oct 2019to 30 Nov 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decreasing Severity of Acne Vulgaris After the Use of a Combination of Anti-Acne Cream in West Jakarta
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.
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- Anti-Acne Preparations for Topical Use
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-Acne Preparations for Topical UseDrug
Combination of anti acne cream that contain active substances such as Clindamycin 3%, Dexamethasone 0.05% and Tretinoin 0.05%
| Study group | Role | What they receive |
|---|---|---|
| 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% Receives: Drug: Anti-Acne Preparations for Topical Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The severity of acne vulgaris is measured after 1 month of use of the combination of anti-acne cream
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start8 Oct 2019
- Primary completion6 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sukma Skin Treatment
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Elizabeth, Sukma Skin Treatment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118296
- Sponsor's protocol ID
- SST-02-2019
- Status last verified
- May 2020
- First submitted
- 3 Oct 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 21108671Ray 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
Cunliffe W, Gollnick H. Topical Theraphy. In Cunliffe WJ GH. Acne Diagnosis and Management. London: Martin Dunitz Ltd; 2001. p. 107-114.
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.
PubMed 18394082Rathi SK. Acne vulgaris treatment : the current scenario. Indian J Dermatol. 2011 Jan;56(1):7-13. doi: 10.4103/0019-5154.77543.
PubMed 21572783
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Severity of Acne Vulgaris After the Use of a Combination of Anti-Acne Cream in West Jakarta
- ClinicalTrials.gov ID
- NCT04118296
- Acronym / sponsor ID
- SST-02-2019
- Conditions
- Acne Vulgaris
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sukma Skin TreatmentUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 6 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Anti-Acne Preparations for Topical UseIntervention 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% |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-Acne Preparations for Topical UseCombination of anti acne cream that contain active substances such as Clindamycin 3%, Dexamethasone 0.05% and Tretinoin 0.05% | Drug | Intervention |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Results publication: PubMed 21108671Perkins 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 publicationRay 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 publicationCunliffe W, Gollnick H. Topical Theraphy. In Cunliffe WJ GH. Acne Diagnosis and Management. London: Martin Dunitz Ltd; 2001. p. 107-114.
- Results publication: PubMed 18394082Katsambas 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 publication: PubMed 21572783Rathi SK. Acne vulgaris treatment : the current scenario. Indian J Dermatol. 2011 Jan;56(1):7-13. doi: 10.4103/0019-5154.77543.
- Acne VulgarisLink provided by the sponsor.
- Clindamycin TopicalLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Anti-Acne Preparations for Topical Use in people with Acne Vulgaris, run by Sukma Skin Treatment at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04118296, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.