Clinical Trial Results: Donoharm Cream Wrapping Mask Efficacy Study
Executive Summary
The Donoharm Cream Wrapping Mask underwent rigorous clinical testing at the Seoul Dermatological Science Research Institute (SDSRI), an independent dermatological research facility, from November 2025 to January 2026. This comprehensive human application study evaluated the mask's effectiveness in improving skin moisture, reducing redness, enhancing skin tone, and controlling sebum through both immediate and sustained efficacy assessments.
Trial Registration
- Study Code: SDSRI-CF007
- IRB Approval: SDSRI-IRB-CF007
- Testing Facility: Seoul Dermatological Science Research Institute
- Principal Investigator: Dr. Hye-Chan Jeon, Board-Certified Dermatologist
- Study Period: November 5, 2025 - January 5, 2026
- Participant Visits: November 19, 2025 - December 16, 2025
Study Design and Methodology
Participants
The clinical trial enrolled 21 healthy adult volunteers (19 female, 2 male) aged 20-49 years (average age: 37.4 years) who met the inclusion criteria and completed the full study protocol. One participant withdrew due to personal reasons, resulting in a 100% compliance rate among completers.
Inclusion Criteria:
- Adults aged 20-49 without acute or chronic physical conditions
- No history of facial skin disease requiring long-term steroid treatment
- Available for follow-up throughout the study period
- Provided voluntary informed consent
Exclusion Criteria:
- Pregnancy, nursing, or possibility of pregnancy
- Skin abnormalities at test site (moles, acne, telangiectasia)
- Cosmetic procedures within 6 months prior to study
- Sensitive or hypersensitive skin
- Use of steroid-containing topical medications for ≥1 month
Testing Protocol
Environmental Controls:
- Temperature: 20-24°C
- Humidity: 40-60% RH
- 30-minute acclimatization period before measurements
Assessment Timeline:
- Baseline (Day 0): Pre-treatment measurements
- Immediate Effect: 3 minutes after single application
- Day 5: After 5 consecutive days of use (once daily)
- Day 12: 7 days post-treatment (durability assessment)
Application Method:
- Apply mask pack to cleansed face
- Leave on for 10-20 minutes
- Remove mask and gently pat remaining essence into skin
- Frequency: Once daily for 5 days
Measurement Equipment
MARK-Vu (PSI PLUS) - AI-Based Skin Analysis System
- Non-invasive imaging technology
- Multi-wavelength light sources (normal, polarized, cross-polarized, UV)
- Quantitative analysis of: redness (erythema), skin tone (RGB brightness), pores, pigmentation, sebum
- Automated AI scoring for objective, reproducible results
Corneometer CM 825 - Skin Hydration Measurement
- Capacitance-based measurement of stratum corneum moisture
- Results expressed in Arbitrary Units (A.U.)
- Higher values indicate better skin hydration
Clinical Results
Primary Endpoint: Skin Moisture Improvement
| Time Point | Mean ± SD (A.U.) | Improvement from Baseline | Statistical Significance |
|---|---|---|---|
| Baseline | 23.19 ± 4.72 | - | - |
| Immediate (3 min) | 44.14 ± 9.96 | +90.34% | p < 0.001 |
| Day 5 | 25.52 ± 5.72 | +10.05% | p = 0.004 |
| Day 12 (Durability) | 25.05 ± 5.12 | +8.02% | p = 0.009 |
Key Finding: A single application of the Donoharm Cream Wrapping Mask produced an immediate 90.34% increase in skin surface moisture, demonstrating exceptional short-term hydration efficacy. The sustained measurements at Day 5 and Day 12 showed statistically significant ongoing moisture improvement, indicating the product supports skin barrier recovery beyond temporary surface hydration.
Secondary Endpoint: Redness Reduction
| Time Point | Mean ± SD | Improvement from Baseline | Statistical Significance |
|---|---|---|---|
| Baseline | 11.24 ± 3.63 | - | - |
| Immediate (3 min) | 9.38 ± 3.50 | -16.55% | p < 0.001 |
| Day 5 | 10.05 ± 3.79 | -10.59% | p = 0.018 |
| Day 12 (Durability) | 9.76 ± 3.62 | -13.17% | p = 0.012 |
Key Finding: Redness decreased by 16.55% immediately after a single application, with sustained anti-inflammatory benefits persisting 7 days after treatment completion (13.17% reduction at Day 12). This suggests the mask provides both immediate soothing and long-term skin calming effects.
Secondary Endpoint: Skin Tone Enhancement
| Time Point | Mean ± SD (RGB) | Improvement from Baseline | Statistical Significance |
|---|---|---|---|
| Baseline | 59.00 ± 2.95 | - | - |
| Immediate (3 min) | 60.62 ± 2.96 | +2.75% | p < 0.001 |
| Day 5 | 60.29 ± 2.90 | +2.19% | p < 0.001 |
| Day 12 (Durability) | 60.10 ± 2.79 | +1.86% | p < 0.001 |
Key Finding: Skin brightness (RGB value) increased by 2.75% after single use, indicating immediate improvement in skin luminosity and radiance. The effect remained statistically significant throughout the follow-up period.
Secondary Endpoint: Sebum Control
| Time Point | Mean ± SD | Improvement from Baseline | Statistical Significance |
|---|---|---|---|
| Baseline | 228.33 ± 183.89 | - | - |
| Immediate (3 min) | 141.33 ± 123.58 | -38.10% | p < 0.001 |
| Day 5 | 231.19 ± 169.61 | No significant change | p = 0.839 |
| Day 12 (Durability) | 209.48 ± 160.59 | No significant change | p = 0.377 |
Key Finding: The mask demonstrated immediate sebum reduction of 38.10%, providing effective short-term oil control. This effect was transient rather than sustained, indicating the product offers immediate mattifying benefits suitable for pre-event use or oily skin management.
Subject Satisfaction Survey Results
Participants rated their satisfaction on a 5-point scale (5: very satisfied, 4: satisfied, 3: neutral, 2: dissatisfied, 1: very dissatisfied). Positive response rate represents participants who rated 3 or above.
After 3-Day Initial Use
| Question | Avg Score | Positive Rate |
|---|---|---|
| Does the mask feel moisturizing? | 3.86 | 100% |
| Did redness improve after 3 days? | 3.85 | 100% |
| Does skin feel smoother after 3 days? | 3.80 | 100% |
| Has skin tone become brighter? | 4.10 | 95% |
| Does skin feel softer and more supple? | 4.25 | 95% |
| Does skin appear more radiant? | 4.35 | 95% |
| Would you continue using this product? | 4.15 | 95% |
| Does it feel gentle on sensitive skin? | 4.05 | 100% |
| Does the mask feel comfortable during application? | 4.25 | 100% |
| Overall satisfaction with 3-day results | 4.15 | 100% |
After 5-Day Complete Usage
| Question | Avg Score | Positive Rate |
|---|---|---|
| Skin feels well-hydrated | 3.86 | 90% |
| Redness has visibly improved | 4.00 | 90% |
| Skin texture has improved | 3.00 | 67% |
| Skin feels firmer | 4.05 | 95% |
| Skin appears more even-toned | 3.90 | 95% |
| Skin feels plumper and more elastic | 3.67 | 86% |
| Skin looks more radiant | 3.76 | 86% |
| Tightness after cleansing has reduced | 3.81 | 90% |
| Makeup application is smoother | 4.14 | 100% |
| Skin tone is brighter | 4.05 | 100% |
| Would recommend to others | 3.81 | 90% |
Safety and Tolerability
Throughout the study period, 5 participants reported mild, transient adverse effects:
- 4 cases: Mild tightness/stiffness
- 1 case: Mild erythema
- 1 case: Mild tingling/prickling
All adverse effects were:
- Mild in severity (Grade 1)
- Transient and self-limiting
- Required no medical intervention
- Did not result in study discontinuation
Safety Conclusion: The Donoharm Cream Wrapping Mask demonstrated an excellent safety profile with no serious adverse reactions reported. The product was well-tolerated by adults with various skin types.
Active Ingredients Supported by Clinical Data
Based on the clinical trial, the following key ingredients contributed to the observed efficacy:
Moisture Barrier Complex
- Ceramide NP: Lipid component essential for skin barrier integrity
- Cholesterol: Works synergistically with ceramides for barrier repair
- Beta-Glucan: Polysaccharide that enhances moisture retention and soothes inflammation
- Hydrogenated Lecithin: Enhances ingredient penetration and barrier function
Hydration Boosters
- Betaine: Natural osmolyte that provides deep hydration
- Panthenol (Provitamin B5): Humectant and skin-soothing agent
- Glycerin: Proven humectant that attracts moisture to skin
Soothing and Anti-Redness Agents
- Centella Asiatica Extract: Traditional wound healing and anti-inflammatory botanical
- Allantoin: Skin-soothing and protective agent
- Lactobacillus Ferment: Probiotic-derived ingredient supporting skin microbiome balance
Luxury Actives
- Black Truffle Extract & White Truffle Extract: Rich in minerals and antioxidants
- Hydrolyzed Collagen: Provides hydration and skin-plumping effects
- rh-Oligopeptide-1 (0.1 ppb): EGF-like peptide supporting skin renewal (human skin identical)
Texture and Stability
- Caprylic/Capric Triglyceride: Lightweight emollient derived from coconut oil
- Butylene Glycol: Multi-functional hydrator and penetration enhancer
- Kaolin: Mineral clay for texture and gentle exfoliation
Scientific Discussion
Mechanism of Action: Why 90% Moisture Improvement?
The exceptional 90.34% immediate moisture improvement can be attributed to a multi-layered hydration approach:
-
Occlusive Effect: The mask creates a temporary occlusive barrier that prevents transepidermal water loss (TEWL), allowing the stratum corneum to rehydrate rapidly.
-
Humectant Delivery: High concentrations of humectants (betaine, panthenol, glycerin) are delivered under occlusion, maximizing moisture binding to the skin surface.
-
Lipid Barrier Support: The ceramide-cholesterol complex mimics the skin's natural lipid composition, supporting immediate and long-term barrier function.
The fact that moisture levels remained elevated (though not at 90%) at Days 5 and 12 suggests the product provides both immediate cosmetic benefits and sustained barrier repair, making it suitable for both quick hydration boosts and ongoing skin health improvement.
Anti-Inflammatory Efficacy
The 16.55% immediate redness reduction and 13.17% sustained improvement at Day 12 indicate genuine anti-inflammatory activity rather than merely cosmetic color correction. This is likely mediated by:
- Centella asiatica: Contains madecassoside and asiaticoside, compounds with documented anti-inflammatory properties
- Beta-glucan: Activates tissue repair mechanisms and reduces inflammatory cytokines
- Lactobacillus ferment: Supports skin microbiome balance, reducing low-grade inflammation
- Panthenol: Converts to pantothenic acid, which has anti-inflammatory effects
The sustained redness reduction 7 days post-treatment suggests the mask doesn't just cool irritated skin temporarily—it actively supports skin recovery processes that continue after product use stops.
Clinical Relevance for Sensitive and Reactive Skin
For individuals with:
- Rosacea-prone skin: The significant redness reduction and excellent tolerability make this mask suitable for calming reactive skin
- Compromised barrier function: The ceramide complex and sustained moisture improvement support barrier repair
- Dehydrated skin: The 90% immediate moisture boost provides rapid relief for tight, uncomfortable skin
- Pre-procedure preparation: The anti-inflammatory and barrier-supporting effects make this suitable for use before/after cosmetic treatments
Study Limitations and Strengths
Limitations
- Short-term study: 2-week duration may not capture long-term efficacy or rare adverse effects
- Small sample size: 21 participants provide preliminary evidence but larger studies would strengthen findings
- Lack of control group: No placebo or comparator product was tested
- Homogeneous population: Primarily Korean adults aged 20-49; results may not generalize to all ethnicities or age groups
Strengths
- Independent testing facility: SDSRI is an independent research institute, not affiliated with the manufacturer
- IRB approval and GCP compliance: Study followed ethical standards and good clinical practice
- Objective measurements: Instrumental assessments (MARK-Vu, Corneometer) reduce subjective bias
- Multiple time points: Immediate, short-term (5 days), and durability (12 days) assessments
- Statistical rigor: All findings reported with p-values and tested for significance
- Complete transparency: Full methodology, raw data, and participant information disclosed in report
Clinical Conclusions
Based on the comprehensive clinical evaluation conducted by Seoul Dermatological Science Research Institute, the Donoharm Cream Wrapping Mask demonstrates clinically significant and statistically verified benefits for:
- Immediate Hydration: 90.34% moisture improvement after single use (p<0.001)
- Redness Reduction: 16.55% immediate improvement, sustained through Day 12 (p<0.05)
- Skin Tone Enhancement: 2.75% brightness improvement maintained over study period (p<0.001)
- Sebum Control: 38.10% immediate reduction for oil management (p<0.001)
- Safety: Excellent tolerability with no serious adverse events
The product is suitable for adults seeking immediate and sustained skin hydration, redness relief, and barrier support, with particular relevance for sensitive, reactive, or compromised skin types.
Study Report: FR-SDSRI-CF007-2025-v1 Clinical Trial Director: Dr. Ji-Eun Kim, Seoul Dermatological Science Research Institute Principal Investigator: Dr. Hye-Chan Jeon, MD, Board-Certified Dermatologist Date of Report: January 5, 2026
This clinical trial was conducted in accordance with the Ministry of Food and Drug Safety (MFDS) Guidelines for Cosmetic Human Application Testing, Good Clinical Practice (GCP) standards, and the Bioethics and Safety Act of the Republic of Korea.