Acne VulgarisPhase 1NCT05497323
Effectivity and Safety of Combination Cream of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad and Zinc PCA
A Phase 1 study testing Combination Cream and Adapalene 0,1% cream in people with Acne Vulgaris, run by Dr.dr.Irma Bernadette, SpKK (K) at 5 sites in Indonesia.
Trial summary
This clinical study will compare the effectivity and safety of combination cream of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad, and Zinc PCA as adjuvant therapy for acne vulgaris patients. These combination cream will be tested by mild to moderate acne vulgaris patients. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Combination Cream and Adapalene 0,1% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 5 sitesIndonesia
- Study dates
- 1 Aug 2022to 1 May 2023
- Phase
- Phase 1
- 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 15 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female aged 15 - 50 years
- Mild and moderate acne vulgaris according to IAEM and GEA.
- Patients are willing to participate in the study until it is finished.
Who cannot join
- History of allergy to dermatocosmetic products.
- Undergoing other acne therapy, medication, or invasive action in the last month.
- Pregnant or breastfeeding patients
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Indonesia5 sites
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Jakarta, DKI Jakarta, 10410
Rumah Sakit Umum Pusat Cipto Mangunkusumo
Jakarta, DKI Jakarta, 10430
Rumah Sakit Umum Daerah Saiful Anwar
Malang, East Java
Rumah Sakit Umum Pusat Dr. M. Djamil
Padang, West Sumatra
Rumah Sakit Umum Daerah Dr. Moewardi
Surakarta, Central Java
About this study
Official title: Effectivity and Safety of Combination Cream of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad and Zinc PCA as Adjuvant Therapy for Acne Vulgaris Mild to Moderate
This clinical study will compare the effectivity and safety of combination cream of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad, and Zinc PCA as adjuvant therapy for acne vulgaris patients. These combination cream will be tested by mild to moderate acne vulgaris patients. Participants will be female patients aged 15-50 years old and divided into three groups. The control group (Group 1) will use Adapalene 0.1% cream only every night. Group 2 will use Adapalene 0.1% cream intermittently every two nights and the combination cream every morning. Group 3 will use Adapalene 0.1% cream every night and the combination cream every morning.
Read the detailed description
This study is an experimental study with a randomized controlled trial (RCT) design on mild to moderate acne vulgaris patients who met the inclusion criteria. This study will be conducted in five Dermatology and Venereology Education Centers in Indonesia located in Jakarta (Rumah Sakit Umum Pusat Nasional dr. Cipto Mangunkusumo), Jakarta (Rumah Sakit Pusat Angkatan Darat Gatot Soebroto), Padang (Rumah Sakit Umum Pusat Dr. M. Djamil), Surakarta (Rumah Sakit Umum Daerah Dr. Moewardi), and Malang (Rumah Sakit Umum Daerah Dr. Saiful Anwar). Group 1 as control group, will receive Adapalene 0.1% cream only every night. Group 2 will receive Adapalene 0.1% cream only intermittently every two nights, and the combination cream every morning. Group 3 will use Adapalene 0.1% cream every night and the combination cream every morning. All participants will be evaluated in day 28 and 56. Therapy evaluation will be assessed based on the Global Acne Severity Scale (GEA Score), Indonesia Acne Expert Meeting (IAEM Score), Level of Seborrhoea, Clinician Erythema Assessment Scale (CEA), facial skin analysis with Janus Skin Facial Analysis, and evaluation of the quality of life using Cardiff Acne Disability Index and Acne-Quality of Life (Acne-QoL) specifically for participants aged older than 18 years old.
- Conditions
- Acne Vulgaris
- Being tested
- Combination Cream, Adapalene 0,1% cream
- Keywords
- combination cream, aqua posae, adjuvant therapy
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination CreamDrug
Also called La Roche Posay, Effaclar Duo (+), dermocosmetic
The combination cream consists of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad and Zinc PCA, were applied every morning by group 2 and group 3.
Adapalene 0,1% creamDrug
Also called Evalen®, topical acne agents
Adapalene 0,1 % cream were given to subjects to be applied every night in group 1 and group 3, and intermittently every two nights in group 2.
| Study group | Role | What they receive |
|---|---|---|
| Combination Cream Group | Experimental | Group 2 will use Adapalene 0.1% cream intermittently every two nights and the combination cream every morning. Group 3 will use Adapalene 0.1% cream every night and the combination cream every morning. Subjects were evaluated on day 28 and day 56. Receives: Drug: Combination Cream |
| Adapalene 0,1% cream | Other | The control group (Group 1) will use Adapalene 0.1% cream only every night. Subjects were evaluated on day 28 and day 56. Receives: Drug: Adapalene 0,1% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of acne severity
Based on Global Acne Severity Scale (GEA Score). On a scale of 0-5, 0 indicates almost no lesions, while 5 indicates severe acne.
Measured: re-evaluation on day 28 and day 56 of therapy
Change of acne severity
Based on Indonesia Acne Expert Meeting (IAEM score). The scale consists of mild, moderate, and severe.
Measured: re-evaluation on day 28 and day 56 of therapy
Change of Level Of Seborrhea
The level of seborrhea is assessed subjectively by participants on a scale of 0 (minimum level) - 10 (maximum level)
Measured: re-evaluation on day 28 and day 56 of therapy
Change of erythema
Based on Clinician Erythema Assessment Scale (CEA) to assess the degree and extent of erythema. The scale ranges from 0-5; 0 indicates no erythema, while 4 indicates severe erythema.
Measured: re-evaluation on day 28 and day 56 of therapy
Change of quality of life
Assessed using Cardiff Acne Disability Index. Cardiff Acne Disability Index questionnaire is an instrument to measure the quality of life of acne vulgaris patients. This instrument has 5 self-answered questions by the patient (for subjects aged≥ 18 years).
Measured: re-evaluation on day 28 and day 56 of therapy
Change of quality of life
Assessed using Acne-Quality of Life. Acne-QoL is an instrument consisting of 19 questions divided into 4 categories: self-perception, social relationships, emotional effects, and acne symptoms. The total score of Acne-QoL is 0-114. The higher total score for each category obtained will interpret that the quality of life of acne vulgaris patients is getting better.
Measured: re-evaluation on day 28 and day 56 of therapy
Facial Analysis Examination With Janus Facial Analysis System
Assessed using the Janus Facial Analysis System®. Janus Facial Analysis System will issue data related to the patient's facial condition.
Measured: re-evaluation on day 28 and day 56 of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Aug 2022
- Primary completion15 Nov 2022
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr.dr.Irma Bernadette, SpKK (K), Universitas Indonesia
- Investigators
- Irma BS Sitohang, MD, Principal investigator, Fakultas Kedokteran Universitas IndonesiaLilik Norawati, MD, Study director, Departemen Ilmu Kesehatan Kulit dan Kelamin Rumah Sakit Pusat Angkatan Darat Gatot Soebroto,Satya WY Yenny, MD, Study director, Departemen Ilmu Kesehatan Kulit dan Kelamin Rumah Sakit Umum Pusat Dr. M. Djamil, PadangArie Kusumawardani, Study director, Departemen Ilmu Kesehatan Kulit dan Kelamin Rumah Sakit Umum Daerah Dr. Moewardi, SurakartaSinta Murlistyarini, Study director, Departemen Ilmu Kesehatan Kulit dan Kelamin Rumah Sakit Umum Daerah Saiful Anwar, Malang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497323
- Sponsor's protocol ID
- EffectivityCombiAquaPosae
- Status last verified
- Apr 2023
- First submitted
- 9 Aug 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivity and Safety of Combination Cream of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad and Zinc PCA as Adjuvant Therapy for Acne Vulgaris Mild to Moderate
- ClinicalTrials.gov ID
- NCT05497323
- Acronym / sponsor ID
- EffectivityCombiAquaPosae
- Conditions
- Acne Vulgaris
- Keywords
- combination cream, aqua posae, adjuvant therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Dr.dr.Irma Bernadette, SpKK (K)University, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 11 Aug 2022 (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 clinical study will compare the effectivity and safety of combination cream of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad, and Zinc PCA as adjuvant therapy for acne vulgaris patients. These combination cream will be tested by mild to moderate acne vulgaris patients. Participants will be female patients aged 15-50 years old and divided into three groups. The control group (Group 1) will use Adapalene 0.1% cream only every night. Group 2 will use Adapalene 0.1% cream intermittently every two nights and the combination cream every morning. Group 3 will use Adapalene 0.1% cream every night and the combination cream every morning.
Detailed description
This study is an experimental study with a randomized controlled trial (RCT) design on mild to moderate acne vulgaris patients who met the inclusion criteria. This study will be conducted in five Dermatology and Venereology Education Centers in Indonesia located in Jakarta (Rumah Sakit Umum Pusat Nasional dr. Cipto Mangunkusumo), Jakarta (Rumah Sakit Pusat Angkatan Darat Gatot Soebroto), Padang (Rumah Sakit Umum Pusat Dr. M. Djamil), Surakarta (Rumah Sakit Umum Daerah Dr. Moewardi), and Malang (Rumah Sakit Umum Daerah Dr. Saiful Anwar). Group 1 as control group, will receive Adapalene 0.1% cream only every night. Group 2 will receive Adapalene 0.1% cream only intermittently every two nights, and the combination cream every morning. Group 3 will use Adapalene 0.1% cream every night and the combination cream every morning. All participants will be evaluated in day 28 and 56. Therapy evaluation will be assessed based on the Global Acne Severity Scale (GEA Score), Indonesia Acne Expert Meeting (IAEM Score), Level of Seborrhoea, Clinician Erythema Assessment Scale (CEA), facial skin analysis with Janus Skin Facial Analysis, and evaluation of the quality of life using Cardiff Acne Disability Index and Acne-Quality of Life (Acne-QoL) specifically for participants aged older than 18 years old.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Cream Group | Experimental | Drug: Combination CreamGroup 2 will use Adapalene 0.1% cream intermittently every two nights and the combination cream every morning. Group 3 will use Adapalene 0.1% cream every night and the combination cream every morning. Subjects were evaluated on day 28 and day 56. |
| Adapalene 0,1% cream | Other | Drug: Adapalene 0,1% creamThe control group (Group 1) will use Adapalene 0.1% cream only every night. Subjects were evaluated on day 28 and day 56. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Female aged 15 - 50 years
- Mild and moderate acne vulgaris according to IAEM and GEA.
- Patients are willing to participate in the study until it is finished.
Key exclusion criteria (3 listed)
- History of allergy to dermatocosmetic products.
- Undergoing other acne therapy, medication, or invasive action in the last month.
- Pregnant or breastfeeding patients
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 |
|---|---|---|
| Combination CreamAlso: La Roche Posay, Effaclar Duo (+), dermocosmeticThe combination cream consists of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad and Zinc PCA, were applied every morning by group 2 and group 3. | Drug | Combination Cream Group |
| Adapalene 0,1% creamAlso: Evalen®, topical acne agentsAdapalene 0,1 % cream were given to subjects to be applied every night in group 1 and group 3, and intermittently every two nights in group 2. | Drug | Adapalene 0,1% cream |
Primary outcome
Change of acne severity
Time frame: re-evaluation on day 28 and day 56 of therapy
Based on Global Acne Severity Scale (GEA Score). On a scale of 0-5, 0 indicates almost no lesions, while 5 indicates severe acne.
Change of acne severity
Time frame: re-evaluation on day 28 and day 56 of therapy
Based on Indonesia Acne Expert Meeting (IAEM score). The scale consists of mild, moderate, and severe.
Change of Level Of Seborrhea
Time frame: re-evaluation on day 28 and day 56 of therapy
The level of seborrhea is assessed subjectively by participants on a scale of 0 (minimum level) - 10 (maximum level)
Change of erythema
Time frame: re-evaluation on day 28 and day 56 of therapy
Based on Clinician Erythema Assessment Scale (CEA) to assess the degree and extent of erythema. The scale ranges from 0-5; 0 indicates no erythema, while 4 indicates severe erythema.
Change of quality of life
Time frame: re-evaluation on day 28 and day 56 of therapy
Assessed using Cardiff Acne Disability Index. Cardiff Acne Disability Index questionnaire is an instrument to measure the quality of life of acne vulgaris patients. This instrument has 5 self-answered questions by the patient (for subjects aged≥ 18 years).
Change of quality of life
Time frame: re-evaluation on day 28 and day 56 of therapy
Assessed using Acne-Quality of Life. Acne-QoL is an instrument consisting of 19 questions divided into 4 categories: self-perception, social relationships, emotional effects, and acne symptoms. The total score of Acne-QoL is 0-114. The higher total score for each category obtained will interpret that the quality of life of acne vulgaris patients is getting better.
Facial Analysis Examination With Janus Facial Analysis System
Time frame: re-evaluation on day 28 and day 56 of therapy
Assessed using the Janus Facial Analysis System®. Janus Facial Analysis System will issue data related to the patient's facial condition.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
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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.
Irma BS Sitohang, MD principal investigator
Fakultas Kedokteran Universitas Indonesia
Lilik Norawati, MD study director
Departemen Ilmu Kesehatan Kulit dan Kelamin Rumah Sakit Pusat Angkatan Darat Gatot Soebroto,
Satya WY Yenny, MD study director
Departemen Ilmu Kesehatan Kulit dan Kelamin Rumah Sakit Umum Pusat Dr. M. Djamil, Padang
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Combination Cream and Adapalene 0,1% cream in people with Acne Vulgaris, run by Dr.dr.Irma Bernadette, SpKK (K) at 5 sites 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change of acne severity (time frame: re-evaluation on day 28 and day 56 of therapy). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2023.