AcneNCT07749469
Safety and Efficacy of Skincare Products for Managing Mild to Moderate Acne in Individuals With Sensitive Skin
A study testing Cleanser, Toner and Serum in people with Acne, run by USMARI Research & Innovation Centre at 1 site in Malaysia.
Trial summary
To investigate the safety and efficacy of a skincare regimen in individuals with mild to moderate acne and sensitive skin. The study duration is 4 weeks and the skin assessment will be carried out at baseline and week 4. The main questions this study aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne
- What is being tested?
- Cleanser, Toner and Serum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jun 2026to 30 Dec 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy Malaysian women and men
- Fitzpatrick skin type II-V
- Age above 18 years old
- Individuals with sensitive skin identify through sensitive skin survey (Corazza et al., 2022) and lactic acid sting test (LAST).
- Individuals with mild to moderate acne, based on Comprehensive Acne Severity Scale (CASS)
Who cannot join
- Pregnant or breastfeeding women, or those planning pregnancy during the study period.
- Individuals with documented autoimmune diseases or other conditions that may affect immune response or skin barrier function.
- Individuals with a history of severe skin sensitivity reactions, including frequent intense erythema, swelling, or intolerable burning in response to topical products.
- Individuals with severe acne requiring medical treatment or systemic treatment such as nodulocystic acne.
- Individuals with active inflammatory or allergic dermatological conditions affecting the face, such as atopic dermatitis, eczema, or psoriasis, which may compromise skin barrier function or interfere with study assessments.
- Individuals who have undergone cosmetic or dermatological procedures such as -chemical peel, microneedling, or any procedures aimed at improving acne, within 3 months prior to the study.
- Individuals currently taking medical or hormonal treatments that may interfere with study outcomes, including anti-inflammatory agents, corticosteroids, or other medication interfering with study objectives.
- Individuals with known allergy or hypersensitivity to any ingredients found in the product.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
USMARI Research & Innovation Centre
Petaling Jaya, Selangor, 47810
Siti Nur Hanis Mamood, PhD, +60167572670, hanis@usmari.org.my
About this study
To investigate the safety and efficacy of a skincare regimen in individuals with mild to moderate acne and sensitive skin. The study duration is 4 weeks and the skin assessment will be carried out at baseline and week 4.
The main questions this study aims to answer are:
- To investigate the safety of the skincare regimen products in managing mild to moderate acne in individuals with sensitive skin.
- To determine the efficacy of the skincare regimen products in managing mild to moderate acne in individuals with sensitive skin.
- To assess the participants' satisfaction with the skincare regimen products in managing mild to moderate acne in individuals with sensitive skin.
- Conditions
- Acne
- Being tested
- Cleanser, Toner, Serum, Day cream, Night cream
- Keywords
- skincare, sensitive skin, acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CleanserOther
Each participant will be provided with a Gentle deep cleanser, 100 mL containing Cocos Nucifera (Coconut) Oil, to be applied for 4 weeks according to the specified instructions.
TonerOther
Each participant will be provided with a Dewy cheeks revitalising toner, 100 mL containing Cocos Nucifera (Coconut) Oil, to be applied for 4 weeks according to the specified instructions.
SerumOther
Each participant will be provided with a Deep serum, 30 mL containing Cocos Nucifera (Coconut) Oil, to be applied for 4 weeks according to the specified instructions.
Day creamOther
Each participant will be provided with a moisturizing day cream, 50 gm containing Cocos Nucifera (Coconut) Oil, to be applied for 4 weeks according to the specified instructions.
Night creamOther
Each participant will be provided with a moisturizing night cream, 50 gm containing Cocos Nucifera (Coconut) Oil, to be applied for 4 weeks according to the specified instructions.
| Study group | Role | What they receive |
|---|---|---|
| Skincare regimen | Other | The skincare regimen consist of cleanser, toner, serum, day cream and night cream Receives: Other: Cleanser; Other: Toner; Other: Serum; Other: Day cream; Other: Night cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive Acne Severity Scale Classification (CASS)
Improvement of acne lesions will be assessed by blinded clinician at W0 and W4 of the study, using CASS. Acne severity was graded using a 6-point scale ranging from Grade 0 (clear) to Grade 5 (very severe). Grade 0 (clear)= No lesions to barely noticeable ones. Very few scattered comedones and papules; Grade 1 (almost clear) = Hardly visible from 2.5 metres away. A few scattered comedones, few small papules, and very few pustules; Grade 2 (mild)= Easily recognisable; less than half of the affected area is involved. Many comedones, papules, and pustules; Grade 3 (moderate)= More than half of the affected area is involved. Numerous comedones, papules, and pustules; Grade 4 (severe)= Entire area is involved. Covered with comedones, numerous pustules and papules, a few nodules and cyst; Grade 5 (very severe)= Highly inflammatory acne covering the affected area, with nodules, and cyst present.
Measured: baseline, week 4
Acne lesion counts
Acne lesion counts will be performed by a blinded clinician. It will involve quantifying the open comedones, closed comedones, papules, pustules, nodules, and cysts. Lesions will be assessed across 5 facial regions: right forehead, left forehead, right cheek, left cheek, and chin. The nose and perinasal area will be excluded from analysis.
Measured: baseline, week 4
Secondary outcomes (2)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The safety of the skincare regimen will be evaluated throughout the study by monitoring adverse events (AEs) reported by participants. The product tolerability will be evaluated using a self-administered questionnaire at week 4. Participants will be asked to rate their level of redness, stinging sensation, tightening, itching, dryness, scaling, and burning on a 6-point scale, with 0 indicating 'none' and 5 indicating 'very severe
Measured: 4 weeks
Participant satisfaction
Participation satisfaction towards product efficacy will be evaluated using a survey. Participants rated their level of agreement with each statement using a 5-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = not sure, 4 = agree, 5 = strongly agree).
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Jun 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- USMARI Research & Innovation Centre
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749469
- Sponsor's protocol ID
- USMR-26-1
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Skincare Products for Managing Mild to Moderate Acne in Individuals With Sensitive Skin
- ClinicalTrials.gov ID
- NCT07749469
- Acronym / sponsor ID
- USMR-26-1
- Conditions
- Acne
- Keywords
- skincare, sensitive skin, acne
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- USMARI Research & Innovation CentreIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 6 Aug 2026 (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.
To investigate the safety and efficacy of a skincare regimen in individuals with mild to moderate acne and sensitive skin. The study duration is 4 weeks and the skin assessment will be carried out at baseline and week 4.
The main questions this study aims to answer are:
- To investigate the safety of the skincare regimen products in managing mild to moderate acne in individuals with sensitive skin.
- To determine the efficacy of the skincare regimen products in managing mild to moderate acne in individuals with sensitive skin.
- To assess the participants' satisfaction with the skincare regimen products in managing mild to moderate acne in individuals with sensitive skin.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skincare regimen | Other | Other: Cleanser, Other: Toner, Other: Serum, Other: Day cream, Other: Night creamThe skincare regimen consist of cleanser, toner, serum, day cream and night cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy Malaysian women and men
- Fitzpatrick skin type II-V
- Age above 18 years old
- Individuals with sensitive skin identify through sensitive skin survey (Corazza et al., 2022) and lactic acid sting test (LAST).
- Individuals with mild to moderate acne, based on Comprehensive Acne Severity Scale (CASS)
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding women, or those planning pregnancy during the study period.
- Individuals with documented autoimmune diseases or other conditions that may affect immune response or skin barrier function.
- Individuals with a history of severe skin sensitivity reactions, including frequent intense erythema, swelling, or intolerable burning in response to topical products.
- Individuals with severe acne requiring medical treatment or systemic treatment such as nodulocystic acne.
- Individuals with active inflammatory or allergic dermatological conditions affecting the face, such as atopic dermatitis, eczema, or psoriasis, which may compromise skin barrier function or interfere with study assessments.
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 |
|---|---|---|
| CleanserEach participant will be provided with a Gentle deep cleanser, 100 mL containing Cocos Nucifera (Coconut) Oil, to be applied for 4 weeks according to the specified instructions. | Other | Skincare regimen |
| TonerEach participant will be provided with a Dewy cheeks revitalising toner, 100 mL containing Cocos Nucifera (Coconut) Oil, to be applied for 4 weeks according to the specified instructions. | Other | Skincare regimen |
| SerumEach participant will be provided with a Deep serum, 30 mL containing Cocos Nucifera (Coconut) Oil, to be applied for 4 weeks according to the specified instructions. | Other | Skincare regimen |
| Day creamEach participant will be provided with a moisturizing day cream, 50 gm containing Cocos Nucifera (Coconut) Oil, to be applied for 4 weeks according to the specified instructions. | Other | Skincare regimen |
| Night creamEach participant will be provided with a moisturizing night cream, 50 gm containing Cocos Nucifera (Coconut) Oil, to be applied for 4 weeks according to the specified instructions. | Other | Skincare regimen |
Primary outcome
Comprehensive Acne Severity Scale Classification (CASS)
Time frame: baseline, week 4
Improvement of acne lesions will be assessed by blinded clinician at W0 and W4 of the study, using CASS. Acne severity was graded using a 6-point scale ranging from Grade 0 (clear) to Grade 5 (very severe). Grade 0 (clear)= No lesions to barely noticeable ones. Very few scattered comedones and papules; Grade 1 (almost clear) = Hardly visible from 2.5 metres away. A few scattered comedones, few small papules, and very few pustules; Grade 2 (mild)= Easily recognisable; less than half of the affected area is involved. Many comedones, papules, and pustules; Grade 3 (moderate)= More than half of the affected area is involved. Numerous comedones, papules, and pustules; Grade 4 (severe)= Entire area is involved. Covered with comedones, numerous pustules and papules, a few nodules and cyst; Grade 5 (very severe)= Highly inflammatory acne covering the affected area, with nodules, and cyst present.
Acne lesion counts
Time frame: baseline, week 4
Acne lesion counts will be performed by a blinded clinician. It will involve quantifying the open comedones, closed comedones, papules, pustules, nodules, and cysts. Lesions will be assessed across 5 facial regions: right forehead, left forehead, right cheek, left cheek, and chin. The nose and perinasal area will be excluded from analysis.
2 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 4 weeks
Participant satisfaction
Time frame: week 4
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 6 Aug 2026.
- Individual participant dataSharing planned: No
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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 study testing Cleanser, Toner and Serum in people with Acne, run by USMARI Research & Innovation Centre at 1 site in Malaysia.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 6 Aug 2026. 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 Malaysia. 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.
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 Siti Nur Hanis Mamood, PhD (+60167572670, hanis@usmari.org.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Acne Severity Scale Classification (CASS) (time frame: baseline, week 4). The study lists 2 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 Aug 2026.