Acne VulgarisPhase 2NCT06925386
The Relationship Between Microbioma Balance and Acne Vulgaris as a New Acne Treatment
A Phase 2 study testing Standard therapy, HEXBIO and Secretome in people with Acne Vulgaris, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
Background: Acne vulgaris is a chronic inflammatory condition primarily caused by Cutibacterium acnes, which disrupts skin homeostasis, thereby triggering immune responses and sebum metabolism. Read more about this study
- Who is it for?
- Ages 13 to 45 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Standard therapy, HEXBIO and Secretome
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2025to 1 May 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 13 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- individuals aged 13 to 45 years
- diagnosed with acne vulgaris by a certified dermatologist, presenting with mild to moderate facial acne based on the lesion count criteria by Lehman et al. Mild acne is defined as having fewer than 20 comedones or fewer than 15 papular/pustular lesions, while moderate acne is characterized by 20-100 comedones and 20-50 papular/pustular lesions.
- must have experienced recurring new acne lesions in the past 6 months
- must be willing to comply with all protocol requirements
- must be willing to have standardized facial photograps taken using an imaging system
- must be able to follow study and adhere to a fixed schedule
- must have ability to provide inform concent for participation in the study
- must be generally healthy and in good mental condition.
Who cannot join
- pregnant patients
- subjects who have undergone hormonal acne treatment within six months prior to the study
- subjects who have taken oral isotretinoin within one month prior to the study.
- simultaneous participation in a different study conducted by an external research institution at the same testing site.
- inadequate language proficiency (both spoken and written)
- participation in the study under the influence of alcohol and/or drugs, as well as substance addiction
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- severe diseases (cardiovascular, hepatic, renal, or pulmonary diseases, severe diabetes mellitus) or chronic infections (Hepatitis, HIV).
- immunodeficiency.
- current use of the following topical or systemic medications: corticosteroids, immunosuppressants, and antihistamines.
- skin conditions such as vitiligo, psoriasis, or atopic dermatitis.
- any other diseases or medications that may directly interfere with the study or pose a risk to the subject's health
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Rumah Sakit Umum Daerah Bali Mandara
Denpasar, Bali, 80116
apt. Ida Ayu Manik Partha Sutema, M.Farm., +6282236350009, idaayumanik85@gmail.com
About this study
Background: Acne vulgaris is a chronic inflammatory condition primarily caused by Cutibacterium acnes, which disrupts skin homeostasis, thereby triggering immune responses and sebum metabolism. Dysbiosis is an imbalances in the skin and gut microbiota identified as a significant factor contributing to acne progression. Standard therapy often rely on antibiotics, but the long-term use has increased antibiotic resistance, including in Indonesia. Consequently, alternative methods, such as probiotics and mesenchymal stromal cell (MSC) secretomes are gaining attention for immunomodulatory and regenerative properties. These novel therapies have shown promising results in modulating the skin and gut microbiota while reducing inflammation.
Study Design: A phase 2 double-blind randomized controlled trial was adopted using a parallel group design with four arms, namely: (1) standard therapy with oral probiotics and topical secretome (placebo), (2) standard therapy with oral probiotics (placebo) and topical secretome, (3) standard therapy with oral probiotics and topical secretome, and (4) standard therapy with oral probiotics (placebo) and topical secretome (placebo). Sixty-four mild to moderate acne vulgaris patients were randomly allocated to these groups. Interventions were administered over a period of 8 weeks, with outcomes measured at baseline and post-therapy. This study was conducted at Dermatology and Venereology Department of Bali Mandara General Hospital (RSBM). The primary outcome is the reduction of comedones and inflammatory lesions, assessed using the Yolov8 method. Secondary outcomes include gut and skin health parameters, such as tryptophan metabolites, collagen, pH, moisture, sebum levels, and IL-6, to explore the relationship between microbiome balance, skin condition, and inflammation in acne.
Discussion: In the context of increasing antibiotic resistance in Indonesia, where therapies often fail to produce sustainable clinical outcomes, this study showed the potential of combining probiotics and MSC secretomes as adjunctive therapies for acne vulgaris. Probiotics restored gut and skin microbiota balance, while MSC secretomes promoted immune modulation and tissue repair. The results of this study paved the way for innovative, non-antibiotic methods for acne management, addressing the need for sustainable and effective therapies amidst growing concerns over dysbiosis and antibiotic resistance.
Read the detailed description
Acne cases have a very high number of visits to doctors, around 87%, especially in teenagers, which has implications for the psychological impact where long treatment with repeated inflammation for quite a long time can have the effect of reducing self-confidence and increasing stress. The therapy that is often given to Acne vulgaris is in the form of long-term topical antibiotics which can risk increasing the bacteria's resistance to antibiotics. Researchers are considering a new therapeutic approach in improving acne vulgaris by improving the balance of the microbiome through consuming oral probiotics so that it can reduce the development of C. acnes bacteria that cause acne and administering serum containing secretome to reduce inflammation/lesions in acne. As proof of the effect of the addition of this new therapy, research was carried out which required 64 research participants who met the criteria and consent from research participants was indicated by agreeing to take part in the research as outlined in the informed consent and research participants were asked to be involved until the research was completed. In research involving humans (participants) who experience mild to moderate acne as determined through examination by a dermatologist to determine the severity of the acne (seen from the total number of acne lesions or bumps), the patients included in the study had an age range of 13 - 45 years, and additional criteria such as: experiencing new acne lesions or bumps repeatedly in the last 6 months, willing to have flash facial images, and physically and mentally healthy. Research participants were given additional therapy from the therapy that should have been given by a doctor. The additional therapy was in the form of oral probiotics which had BPOM distribution permits and topical secretome in the form of facial serum. Participants will be divided into 4 groups randomly so that respondents are selected fairly and objectively. All drugs/test materials use natural ingredients which tend to be very safe with low side effects, oral probiotics have been reported in a few cases with diarrhea and secretome side effects with a very low possibility of skin redness, but to further increase safety, researchers will carry out a skin redness test first. first on the skin before being given the test material, and if changes occur such as loose stools and repeated bowel movements more than 3 times a day, the researchers have prepared medication as a preventive measure, and if it continues, it will be fully handled by the researchers. The development of new therapies, especially skin diseases, in this case Acne vulgaris, needs to be explored, one of which is through the microbiome approach and new regenerating medicine using stem cells (secretome). In this study, researchers want to prove that natural ingredient-based treatments, namely oral probiotics and topical secretome, can have the potential to improve acne vulgaris through measuring microbiome balance and severity, so in this study a clinical trial will be carried out to compare the effects of standard therapy (usual therapy) with additional oral probiotic therapy and topical secretome on its ability to increase clinical and microbiome improvement in moderate-severe Acne vulgaris patients through a double-blended open label Randomized Control Trial study.
- Conditions
- Acne Vulgaris
- Being tested
- Standard therapy, HEXBIO, Secretome
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard therapyDrug
The standard therapy for participants included a structured skincare regimen. A face wash was used once daily before bedtime to cleanse the skin. In the morning, a non-comedogenic sunscreen and a moisturizer were applied to protect and hydrate the skin. Additionally, a night cream containing clindamycin and tretinoin was applied once daily at night, specifically on acne-affected areas, to target inflammation and promote skin renewal.
HEXBIODietary supplement
The oral probiotics given are Hexbio®, an oral probiotic containing multiple beneficial bacterial strains, including Lactobacillus acidophilus BCMC® 12130, Lactobacillus casei BCMC® 12313, Lactobacillus lactis BCMC® 12451, Bifidobacterium bifidum BCMC®02290, Bifidobacterium longum BCMC® 02120, and Bifidobacterium infantis BCMC®02129. This probiotic was administered in granule form and swallowed directly. Participants consumed the probiotic twice daily, after breakfast and dinner, for eight weeks to support gut microbiome balance and potential skin health benefits.
SecretomeBiological
The topical secretome used is a hydrogel-based serum containing secretome components, including cytokines, growth factors, exosomes, microvesicles, and cell differentiation factors. The serum is formulated with a hydrogel base consisting of xanthan gum, sclerotium gum, 1% alginate, 2% glycerin, 1% caprylyl glycol, and 96% aqua. It is applied after cleansing the face with a facial cleanser, twice daily, in the morning and evening, for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Standard therapy + oral probiotics + topical secretome (placebo) Receives: Drug: Standard therapy; Dietary Supplement: HEXBIO |
| Group 2 | Experimental | Standard therapy + oral probiotics (placebo) + topical secretome Receives: Drug: Standard therapy; Biological: Secretome |
| Group 3 | Experimental | Standard therapy + oral probiotics + topical secretome Receives: Drug: Standard therapy; Dietary Supplement: HEXBIO; Biological: Secretome |
| Group 4 | Placebo comparator | Standard therapy + oral probiotics (placebo) + topical secretome (placebo) Receives: Drug: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of comedones and inflammatory lesions
The primary outcome measured in this study is the reduction in the number of comedones and/or inflammatory lesions (papules/pustules). This is assessed using the Yolov8 machine learning detection method, which enables accurate and objective quantification of comedones and lesions while also determining the severity of acne
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (6)
Tryptophan metabolites
In the gut, tryptophan metabolites are measured using the ELISA method to assess the abundance of probiotic bacteria, specifically lactic acid bacteria such as Lactobacillus and Bifidobacterium
Measured: From enrollment to the end of treatment at 8 weeks
Inflammatory Response
Inflammatory responses are assessed by measuring serum IL-6 levels, which serve as an indicator of systemic inflammation
Measured: From enrollment to the end of treatment at 8 weeks
Collagen Measurement
collagen measurement use skin Elastometer
Measured: From enrollment to the end of treatment at 8 weeks
Moisture content
Moisture content use skin hydrometer
Measured: From enrollment to the end of treatment at 8 weeks
Sebum levels
Sebum levels use sebumeter
Measured: From enrollment to the end of treatment at 8 weeks
pH levels
pH levels use pH meter to determine the balance of the skin microbiome
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel group design with four arms was used, (1) standard therapy with oral probiotics and topical secretome (placebo), (2) standard therapy with oral probiotics (placebo) and topical secretome, (3) standard therapy with oral probiotics and topical secretome, and (4) standard therapy with oral probiotics (placebo) and topical secretome (placebo). Participants were assigned to groups using a random permuted block sampling method (comprising A, B, C, D). This method is commonly applied in clinical trials including small sample sizes with staggered participants' enrollment. Observation spans 8 weeks. All groups were subjected to pretest and posttest assessments, measuring acne severity, fecal microbiome metabolites, skin condition, and IL-6 before and after intervention.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Collaborators
- PT. Prodia Stem Cell Indonesia, B-Crobes Laboratory
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925386
- Sponsor's protocol ID
- PHAR-202503.01
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lestari K, Sutema IAMP, Latarissa IR, Oon SF, Tamsir NM, Noor A, Widowati IGAR, Sartika CR, Ciptasari NWE. Oral probiotics and topical secretome to enhance clinical outcomes and microbiome restoration in acne vulgaris: a double-blind, randomised controlled trial protocol. BMJ Open. 2026 Jun 4;16(6):e109586. doi: 10.1136/bmjopen-2025-109586.
PubMed 42242743
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Microbioma Balance and Acne Vulgaris as a New Acne Treatment
- ClinicalTrials.gov ID
- NCT06925386
- Acronym / sponsor ID
- PHAR-202503.01
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Collaborators
- PT. Prodia Stem Cell Indonesia, B-Crobes Laboratory
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 13 Apr 2025 (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.
Background: Acne vulgaris is a chronic inflammatory condition primarily caused by Cutibacterium acnes, which disrupts skin homeostasis, thereby triggering immune responses and sebum metabolism. Dysbiosis is an imbalances in the skin and gut microbiota identified as a significant factor contributing to acne progression. Standard therapy often rely on antibiotics, but the long-term use has increased antibiotic resistance, including in Indonesia. Consequently, alternative methods, such as probiotics and mesenchymal stromal cell (MSC) secretomes are gaining attention for immunomodulatory and regenerative properties. These novel therapies have shown promising results in modulating the skin and gut microbiota while reducing inflammation.
Study Design: A phase 2 double-blind randomized controlled trial was adopted using a parallel group design with four arms, namely: (1) standard therapy with oral probiotics and topical secretome (placebo), (2) standard therapy with oral probiotics (placebo) and topical secretome, (3) standard therapy with oral probiotics and topical secretome, and (4) standard therapy with oral probiotics (placebo) and topical secretome (placebo). Sixty-four mild to moderate acne vulgaris patients were randomly allocated to these groups. Interventions were administered over a period of 8 weeks, with outcomes measured at baseline and post-therapy. This study was conducted at Dermatology and Venereology Department of Bali Mandara General Hospital (RSBM). The primary outcome is the reduction of comedones and inflammatory lesions, assessed using the Yolov8 method. Secondary outcomes include gut and skin health parameters, such as tryptophan metabolites, collagen, pH, moisture, sebum levels, and IL-6, to explore the relationship between microbiome balance, skin condition, and inflammation in acne.
Discussion: In the context of increasing antibiotic resistance in Indonesia, where therapies often fail to produce sustainable clinical outcomes, this study showed the potential of combining probiotics and MSC secretomes as adjunctive therapies for acne vulgaris. Probiotics restored gut and skin microbiota balance, while MSC secretomes promoted immune modulation and tissue repair. The results of this study paved the way for innovative, non-antibiotic methods for acne management, addressing the need for sustainable and effective therapies amidst growing concerns over dysbiosis and antibiotic resistance.
Detailed description
Acne cases have a very high number of visits to doctors, around 87%, especially in teenagers, which has implications for the psychological impact where long treatment with repeated inflammation for quite a long time can have the effect of reducing self-confidence and increasing stress. The therapy that is often given to Acne vulgaris is in the form of long-term topical antibiotics which can risk increasing the bacteria's resistance to antibiotics. Researchers are considering a new therapeutic approach in improving acne vulgaris by improving the balance of the microbiome through consuming oral probiotics so that it can reduce the development of C. acnes bacteria that cause acne and administering serum containing secretome to reduce inflammation/lesions in acne. As proof of the effect of the addition of this new therapy, research was carried out which required 64 research participants who met the criteria and consent from research participants was indicated by agreeing to take part in the research as outlined in the informed consent and research participants were asked to be involved until the research was completed. In research involving humans (participants) who experience mild to moderate acne as determined through examination by a dermatologist to determine the severity of the acne (seen from the total number of acne lesions or bumps), the patients included in the study had an age range of 13 - 45 years, and additional criteria such as: experiencing new acne lesions or bumps repeatedly in the last 6 months, willing to have flash facial images, and physically and mentally healthy. Research participants were given additional therapy from the therapy that should have been given by a doctor. The additional therapy was in the form of oral probiotics which had BPOM distribution permits and topical secretome in the form of facial serum. Participants will be divided into 4 groups randomly so that respondents are selected fairly and objectively. All drugs/test materials use natural ingredients which tend to be very safe with low side effects, oral probiotics have been reported in a few cases with diarrhea and secretome side effects with a very low possibility of skin redness, but to further increase safety, researchers will carry out a skin redness test first. first on the skin before being given the test material, and if changes occur such as loose stools and repeated bowel movements more than 3 times a day, the researchers have prepared medication as a preventive measure, and if it continues, it will be fully handled by the researchers. The development of new therapies, especially skin diseases, in this case Acne vulgaris, needs to be explored, one of which is through the microbiome approach and new regenerating medicine using stem cells (secretome). In this study, researchers want to prove that natural ingredient-based treatments, namely oral probiotics and topical secretome, can have the potential to improve acne vulgaris through measuring microbiome balance and severity, so in this study a clinical trial will be carried out to compare the effects of standard therapy (usual therapy) with additional oral probiotic therapy and topical secretome on its ability to increase clinical and microbiome improvement in moderate-severe Acne vulgaris patients through a double-blended open label Randomized Control Trial study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A parallel group design with four arms was used, (1) standard therapy with oral probiotics and topical secretome (placebo), (2) standard therapy with oral probiotics (placebo) and topical secretome, (3) standard therapy with oral probiotics and topical secretome, and (4) standard therapy with oral probiotics (placebo) and topical secretome (placebo). Participants were assigned to groups using a random permuted block sampling method (comprising A, B, C, D). This method is commonly applied in clinical trials including small sample sizes with staggered participants' enrollment. Observation spans 8 weeks. All groups were subjected to pretest and posttest assessments, measuring acne severity, fecal microbiome metabolites, skin condition, and IL-6 before and after intervention.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Standard therapy, Dietary Supplement: HEXBIOStandard therapy + oral probiotics + topical secretome (placebo) |
| Group 2 | Experimental | Drug: Standard therapy, Biological: SecretomeStandard therapy + oral probiotics (placebo) + topical secretome |
| Group 3 | Experimental | Drug: Standard therapy, Dietary Supplement: HEXBIO, Biological: SecretomeStandard therapy + oral probiotics + topical secretome |
| Group 4 | Placebo comparator | Drug: Standard therapyStandard therapy + oral probiotics (placebo) + topical secretome (placebo) |
Who may qualify
- Ages
- 13 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- individuals aged 13 to 45 years
- diagnosed with acne vulgaris by a certified dermatologist, presenting with mild to moderate facial acne based on the lesion count criteria by Lehman et al. Mild acne is defined as having fewer than 20 comedones or fewer than 15 papular/pustular lesions, while moderate acne is characterized by 20-100 comedones and 20-50 papular/pustular lesions.
- must have experienced recurring new acne lesions in the past 6 months
- must be willing to comply with all protocol requirements
- must be willing to have standardized facial photograps taken using an imaging system
Key exclusion criteria (11 listed)
- pregnant patients
- subjects who have undergone hormonal acne treatment within six months prior to the study
- subjects who have taken oral isotretinoin within one month prior to the study.
- simultaneous participation in a different study conducted by an external research institution at the same testing site.
- inadequate language proficiency (both spoken and written)
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 |
|---|---|---|
| Standard therapyThe standard therapy for participants included a structured skincare regimen. A face wash was used once daily before bedtime to cleanse the skin. In the morning, a non-comedogenic sunscreen and a moisturizer were applied to protect and hydrate the skin. Additionally, a night cream containing clindamycin and tretinoin was applied once daily at night, specifically on acne-affected areas, to target inflammation and promote skin renewal. | Drug | Group 1, Group 2, Group 3, Group 4 |
| HEXBIOThe oral probiotics given are Hexbio®, an oral probiotic containing multiple beneficial bacterial strains, including Lactobacillus acidophilus BCMC® 12130, Lactobacillus casei BCMC® 12313, Lactobacillus lactis BCMC® 12451, Bifidobacterium bifidum BCMC®02290, Bifidobacterium longum BCMC® 02120, and Bifidobacterium infantis BCMC®02129. This probiotic was administered in granule form and swallowed directly. Participants consumed the probiotic twice daily, after breakfast and dinner, for eight weeks to support gut microbiome balance and potential skin health benefits. | Dietary supplement | Group 1, Group 3 |
| SecretomeThe topical secretome used is a hydrogel-based serum containing secretome components, including cytokines, growth factors, exosomes, microvesicles, and cell differentiation factors. The serum is formulated with a hydrogel base consisting of xanthan gum, sclerotium gum, 1% alginate, 2% glycerin, 1% caprylyl glycol, and 96% aqua. It is applied after cleansing the face with a facial cleanser, twice daily, in the morning and evening, for eight weeks | Biological | Group 2, Group 3 |
Primary outcome
Reduction of comedones and inflammatory lesions
Time frame: From enrollment to the end of treatment at 8 weeks
The primary outcome measured in this study is the reduction in the number of comedones and/or inflammatory lesions (papules/pustules). This is assessed using the Yolov8 machine learning detection method, which enables accurate and objective quantification of comedones and lesions while also determining the severity of acne
6 secondary outcomes
Tryptophan metabolites
Time frame: From enrollment to the end of treatment at 8 weeks
Inflammatory Response
Time frame: From enrollment to the end of treatment at 8 weeks
Collagen Measurement
Time frame: From enrollment to the end of treatment at 8 weeks
Moisture content
Time frame: From enrollment to the end of treatment at 8 weeks
Sebum levels
Time frame: From enrollment to the end of treatment at 8 weeks
pH levels
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Derived from this study: PubMed 42242743Lestari K, Sutema IAMP, Latarissa IR, Oon SF, Tamsir NM, Noor A, Widowati IGAR, Sartika CR, Ciptasari NWE. Oral probiotics and topical secretome to enhance clinical outcomes and microbiome restoration in acne vulgaris: a double-blind, randomised controlled trial protocol. BMJ Open. 2026 Jun 4;16(6):e109586. doi: 10.1136/bmjopen-2025-109586.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard therapy, HEXBIO and Secretome in people with Acne Vulgaris, run by Universitas Padjadjaran 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 8 inclusion and 11 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: opening soon, as of the sponsor's last update on 13 Apr 2025. 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. Some participants in this study may receive a placebo. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact apt. Ida Ayu Manik Pharta Sutema, M.Farm., Researcher (+6282236350009, idaayumanik85@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of comedones and inflammatory lesions (time frame: From enrollment to the end of treatment at 8 weeks). 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 NCT06925386, which also lists 1 linked publication.
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 13 Apr 2025.