Acne
Conditions
Keywords
skincare, sensitive skin, acne
Brief 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. To investigate the safety of the skincare regimen products in managing mild to moderate acne in individuals with sensitive skin. 2. To determine the efficacy of the skincare regimen products in managing mild to moderate acne in individuals with sensitive skin. 3. To assess the participants' satisfaction with the skincare regimen products in managing mild to moderate acne in individuals with sensitive skin.
Interventions
OTHERCleanser
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.
OTHERToner
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.
OTHERSerum
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.
OTHERDay cream
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.
OTHERNight cream
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.
Sponsors
USMARI Research & Innovation Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comprehensive Acne Severity Scale Classification (CASS) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 4 weeks | 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 |
| Participant satisfaction | week 4 | 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). |
Countries
Malaysia
Contacts
CONTACTSiti Nur Hanis Mamood, PhD
Outcome results
None listed