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

NCT07749469 | Recruiting

• 1 other identifier: USMR-26-1
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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. 1.To investigate the safety of the skincare regimen products in managing mild to moderate acne in individuals with sensitive skin.
2. 2.To determine the efficacy of the skincare regimen products in managing mild to moderate acne in individuals with sensitive skin.
3. 3.To assess the participants' satisfaction with the skincare regimen products in managing mild to moderate acne in individuals with sensitive skin.

Conditions

Acne

Keywords

skincare; sensitive skin; acne

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  baseline, week 4

Secondary Outcomes (2)

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

  4 weeks

• Participant satisfaction

  week 4

Study Arms (1)

Skincare regimen

OTHER

The skincare regimen consist of cleanser, toner, serum, day cream and night cream

Other: Cleanser; Other: Toner; Other: Serum; Other: Day cream; Other: Night cream

Interventions

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.

Skincare regimen

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.

Skincare regimen

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.

Skincare regimen

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.

Skincare regimen

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.

Skincare regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• USMARI Research & Innovation Centre: lead

Study Sites (1)

USMARI Research & Innovation Centre

Petaling Jaya, Selangor, 47810, Malaysia

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Central Study Contacts

Siti Nur Hanis Mamood, PhD

CONTACT

+60167572670; hanis@usmari.org.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 6, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)