whiteORA Mela 5D Serum — Clinical Efficacy Study

01 —

Study Design

Study Title

A clinical study of WHITEORA MELA 5D SERUM to assess melasma area (density) and prevention of melasma, dark spots, and pigmentation regeneration (maintenance of pigmentation improvement), triple skin tone (yellowness, soothing, brightness) and pigmentation, mottled skin tone (uniformity), deep skin melanin (inner melasma), and skin surface melanin (surface melasma)

Subjects

23 females, ages 20–59
Mean age: 51.70 years
All with existing pigmentation (melasma, dark spots, freckles)

Protocol

4 weeks twice-daily use (AM & PM)
+ 1-week post-discontinuation follow-up
Study: July 22 – September 1, 2025

Application

After cleansing, apply evenly after toner. No other whitening or wrinkle-improvement functional cosmetics permitted during study period.

Statistics

Repeated Measures ANOVA + Bonferroni correction (parametric) · Friedman test + Wilcoxon signed-rank + Bonferroni (non-parametric) · Significance: p<0.05

02 —

Assessment Timeline — 5 Visits

Tap a visit node to see what was assessed.

V1

Baseline

Before use

V2

Day 1

After 1st application

V3

Week 2

Mid-point

V4

Week 4

Primary endpoint

V5

+1 Wk Post

After discontinuation

Measurement instruments: Antera 3D CS (melasma area/density) · VISIA-CR → Image-pro® plus (triple skin tone L*a*b*, pigmentation pixel count, skin uniformity, deep melanin) · DermaVision (surface melasma red-area %). Protocol compliance: 99.76% across all 23 subjects (range 96.4–100%). Zero dropouts.

03 —

All 8 Endpoints at a Glance — 4-Week Improvement

Mean % Improvement from Baseline to Week 4 (Cohort, n=23)

Individual-subject average improvements from the study analysis. All 8 endpoints statistically significant (p<0.05).

04 —

Primary Efficacy Results — All 8 Metrics

Tap any metric card to expand the trend chart. All improvement rates are statistically significant. All results maintained 1 week after discontinuation with no significant rebound.

04b —

Visual Evidence — Best-Case Subject per Endpoint

Clinical imaging data for the highest-performing subject on each of the 8 endpoints. Five assessment timepoints shown side-by-side: Baseline → Day 1 → Week 2 → Week 4 → Post-Discontinuation. Click any image to inspect it full-screen with zoom. Eyes are obscured per standard clinical research protocol.

Skin Surface Melanin

Top Responder · Subject W1-15

−88.9%

Surface Melasma at 4 Weeks

Clinical image — Skin Surface Melanin — Subject W1-15

BaselineDay 1Week 2Week 4Post-Disc

Click to inspect

DermaVision thermal mapping. Warm colours indicate active surface melanin. Progressive clearance across all 5 timepoints in the top-performing subject. Cohort mean: −41.7%.

DermaVision · Thermal heat map · Red area %

Pigmentation

Top Responder · Subject W1-04

−37.5%

Pigmented Pixels at 4 Weeks

Clinical image — Pigmentation — Subject W1-04

BaselineDay 1Week 2Week 4Post-Disc

Click to inspect

Antera 3D CS: the analysed view (bottom row) marks each pigmented lesion within the measurement circle. Visible reduction in spot density and intensity from Baseline to Week 4.

Antera 3D CS · Original + analysed overlay · Pixel count

Melasma Area Density

Top Responder · Subject W1-04

−29.3%

Melasma-Affected Area at 4 Weeks

Clinical image — Melasma Area Density — Subject W1-04

BaselineDay 1Week 2Week 4Post-Disc

Click to inspect

VISIA-CR full-face melanin density map. Warm false-colour tones mark melanin distribution. The progressive lightening from Visit 1 to Visit 4 reflects a 29.3% reduction in affected area.

VISIA-CR → Image-pro® plus · Full-face melanin density map · mm²

Mottled Skin Tone

Top Responder · Subject W1-08

−27.4%

Uniformity at 4 Weeks

Clinical image — Mottled Skin Tone — Subject W1-08

BaselineDay 1Week 2Week 4Post-Disc

Click to inspect

Standardised clinical photography under controlled lighting conditions. Reduction in tone irregularity and mottled appearance measured as intensity standard deviation.

VISIA-CR standardised photography · Intensity std

Skin Soothing (a*)

Top Responder · Subject W1-18

−14.2%

Redness Reduction at 4 Weeks

Clinical image — Skin Soothing (a*) — Subject W1-18

BaselineDay 1Week 2Week 4Post-Disc

Click to inspect

CIELab photography across 5 timepoints. Reduction in a* (redness axis) indicates a progressively calmer, less inflamed complexion. Significant from Day 1 (p=0.004).

VISIA-CR → CIELab colorimetry · a* redness axis

Skin Yellowness (b*)

Top Responder · Subject W1-22

−12.1%

Yellowness Reduction at 4 Weeks

Clinical image — Skin Yellowness (b*) — Subject W1-22

BaselineDay 1Week 2Week 4Post-Disc

Click to inspect

CIELab colorimetry: b* axis. Reduction indicates clearance of the brownish-yellow pigment cast. Visible improvement in skin clarity from Baseline to Week 4 and maintained post-discontinuation.

VISIA-CR → CIELab colorimetry · b* yellowness axis

Skin Brightness (L*)

Top Responder · Subject W1-18

+2.82%

Luminance Increase at 4 Weeks

Clinical image — Skin Brightness (L*) — Subject W1-18

BaselineDay 1Week 2Week 4Post-Disc

Click to inspect

Standard clinical photography documenting measurable brightening of skin luminance. The L* axis is the most intuitive metric for patients. Significant improvement from Day 1 (p=0.000).

VISIA-CR → CIELab colorimetry · L* luminance axis

Deep Skin Melanin

Top Responder · Subject W1-21

+10.5%

Inner Melasma at 4 Weeks

Clinical image — Deep Skin Melanin — Subject W1-21

BaselineDay 1Week 2Week 4Post-Disc

Click to inspect

VISIA-CR UV imaging captures dermal melanin deposits. Higher intensity = less melanin absorption = melanin cleared from the dermis — the deep layer responsible for melasma recurrence.

VISIA-CR UV illumination · Intensity · Inner melasma

05 —

Measurable Effects After a Single Application

Four of the eight primary endpoints reached statistical significance after just 1 day of use — a rare finding in topical brightening trials where meaningful change typically requires 2–4 weeks.

Triple Tone · Brightness (L*)

Skin luminance increase after Day 1

0.54%

Wk2: 1.21% Wk4: 1.60%

74.599 → 75.003 L* on Day 1 · p=0.000 · All timepoints significant

Triple Tone · Yellowness (b*)

Pigment-cast yellowness reduction

0.51%

Wk2: 2.53% Wk4: 3.87%

23.962 → 23.840 b* on Day 1 · p=0.001 · 100% responder rate

Triple Tone · Soothing (a*)

Skin redness/inflammation reduction

2.41%

Wk2: 3.75% Wk4: 5.49%

11.668 → 11.387 a* on Day 1 · p=0.004 · 91.3% responder rate

Skin Tone Uniformity (Mottling)

Significant improvement in tone evenness after first application

0.75%

Wk2: 6.81% Wk4: 12.18% Post-Disc: Maintained

Intensity std 2.012 → 1.997 on Day 1 · p=0.002 · 100% responder rate (23/23) · All improvements maintained post-discontinuation

Triple Skin Tone — 5-Timepoint Trend

Group mean values across 5 assessment visits. Significant improvement visible from Day 1.

06 —

Key Findings — Evidence-Based Claims

Derived from individual-level analysis of the full cohort dataset (n=23). All backed by the original study data.

Surface Melasma Clearance Over Time

Group mean Red Area (%) across 5 timepoints. Instrument: DermaVision.

Pigmentation Reduction — Total Pixel Count

Group mean pigmented pixel count (VISIA-CR image analysis). 100% responder rate — every subject showed measurable improvement.

07 —

Subject Spotlight — Top 3 Composite Responders

Ranked by weighted composite score across all 8 metrics (melasma area 25%, pigmentation 20%, surface melanin 20%, brightness 10%, uniformity 10%, deep melanin 10%, yellowness 2.5%, redness 2.5%). Individual subject data from the study appendices.

08 —

Subject-Reported Surveys

Scale: 5 = Very Good · 4 = Good · 3 = Moderate · 2 = Bad · 1 = Very Bad

Helps improve melasma area (density) — melasma reduction effect — and prevent melasma, dark spots, and pigmentation regeneration (maintain pigmentation improvement)

4.39

100%

Helps improve triple skin tone (yellowness, soothing, brightness) and pigmentation

4.52

100%

Helps improve mottled skin tone (uniformity)

4.22

100%

Helps improve skin surface melanin (reduce surface melasma)

4.48

100%

All 4 efficacy parameters: 100% of subjects rated ≥ Moderate. 0 subjects rated any parameter as Bad or Very Bad. Efficacy was rated "Good" or "Very Good" by every single participant across every parameter.

Scale: 5 = Very Good · 4 = Good · 3 = Moderate · 2 = Bad · 1 = Very Bad

Skin hydration

4.65

100%

Skin smoothness

4.78

100%

Scent

4.22

100%

Note on Q9: This question ("Did you experience any skin irritation?") is a product preference/experience rating (5=Very Good experience, 1=Very Bad). The formal clinical safety evaluation by the researcher (Table 20–22) found zero adverse reactions across all 23 subjects at all visits.

09 —

Safety & Tolerability Profile

0

Adverse Events

No adverse reactions identified throughout the 4-week protocol and 1-week follow-up

0

Clinical Signs

No erythema, no edema, no scaling — confirmed by researcher visual evaluation at every visit

0

Subject Complaints

No itching, stinging, burning, tightness, or prickling reported in formal safety questionnaires

0

Dropouts

All 23 enrolled subjects completed all 5 visits. Zero early terminations or withdrawals

Protocol Compliance

99.8%

Mean compliance: 99.763% · Range: 96.364%–100.000% · No subject below 80% threshold · All 23 datasets included in analysis

Formal safety assessment methodology: Researcher clinical visual evaluation of test site at each of 5 visits (erythema, edema, scaling); subject adverse-event questionnaire (itching, stinging, burning, tightness, prickling); adverse event log with occurrence and action record. All three instruments returned zero findings. The product demonstrated an excellent tolerability profile throughout the full study period including post-discontinuation follow-up.

10 —

Study Conclusion

After 1 application (Day 1):

Skin brightness (L*) significantly improved

Skin yellowness (b*) significantly improved

Skin soothing / redness (a*) significantly improved

Skin tone uniformity significantly improved

After 2 weeks:

All 8 primary endpoints reached significance

Surface melanin: −24.9%

Pigmentation: −16.8%

After 4 weeks:

Surface melanin: −41.7% (group mean)

Pigmentation pixel count: −24.6%

Melasma area density: −11.8%

Skin uniformity: −12.2%

1 week post-discontinuation:

All 8 improvements fully maintained

Zero significant rebound on any endpoint

Durable effect beyond active treatment window

A clinically proven
multi-pathway
brightening protocol.

WHITEORA MELA 5D SERUM demonstrated statistically significant improvement across all 8 primary measurement endpoints. Critically, 4 of 8 endpoints showed measurable improvement from Day 1, and all improvements were fully maintained one week after discontinuation — with no statistically significant rebound on any metric.

The 41.7% reduction in skin surface melanin at 4 weeks (p<0.0125), combined with 100% responder rate across 6 of 8 metrics and zero adverse events over 23 subjects, establishes a strong efficacy and safety profile suitable for use in medical aesthetics protocols including post-laser, post-peel, and active melasma management.

100% of subjects reported ≥ Moderate satisfaction across all 4 efficacy parameters. Protocol compliance: 99.8%.

CLINICAL EFFICACY STUDY · HUMAN APPLICATION TEST · SEPTEMBER 2025
STUDY CONDUCTED IN ACCORDANCE WITH APPLICABLE STANDARD OPERATING PROCEDURES
FOR PROFESSIONAL USE ONLY — INTENDED FOR HEALTHCARE PROFESSIONALS

Study Completed

September 2025

Statistical Methods

Repeated Measures ANOVA + Bonferroni · Friedman + Wilcoxon-Bonferroni

Subjects

23 females · Ages 20–59 · Mean age 51.70 · 100% completion rate

Significance Threshold

p < 0.05 · All 8 primary endpoints significant at 2wk and 4wk