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Recruiting NCT07749469

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

No phase Interventional Acne

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cleanser, Toner, Serum, Day cream.
Who it may be relevant to
Registry conditions: Acne. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Malaysia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Other Cleanser
    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.
  • Other Toner
    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.
  • Other Serum
    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.
  • Other Day 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.
  • Other Night 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.

Primary outcome measures

  • Comprehensive Acne Severity Scale Classification (CASS) [Time frame: baseline, week 4]
  • Acne lesion counts [Time frame: baseline, week 4]
Secondary outcome measures (2)
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time frame: 4 weeks]
  • Participant satisfaction [Time frame: week 4]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Malaysia · 1 center
  • USMARI Research & Innovation Centre — Petaling Jaya

Identifiers

NCT: NCT07749469 · USMR-26-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗