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NCT Number: NCT07749469

Safety and Efficacy of Skincare Products for Managing Mild to Moderate Acne in Individuals With Sensitive Skin

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.

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USMARI Research & Innovation Centre

Petaling Jaya, Selangor, 47810, Malaysia

Location status: Recruiting

Location contact

Siti Nur Hanis Mamood, PhD

CONTACT

[email protected]

+60167572670

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cleanser

Other

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.

Toner

Other

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.

Serum

Other

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 cream

Other

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 cream

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: 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

  2. Participant satisfaction

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Siti Nur Hanis Mamood, PhD

CONTACT

[email protected]

+60167572670

Sponsors and collaborators

Lead sponsor

USMARI Research & Innovation Centre

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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