Clinical Validation

The data speaks
for itself.

A double-blind, placebo-controlled trial conducted at the Lugano Institute of Dermoscopic Research (2022) under lead investigator Dr. Matthias Orel. 144 participants. 28 days. p = 0.0031.

Primary & Secondary Outcomes

73.4%

Primary

Reduction in periorbital hyperpigmentation (Mexameter® MX18 colorimetry)

p = 0.0031n = 144

81.2%

Secondary

Improvement in skin elasticity index (Cutometer® MPA 580)

p = 0.0019n = 144

68.9%

Tertiary

Reduction in transepidermal water loss — TEWL (Tewameter® TM 300)

p = 0.0047n = 141

Trial Design

Study methodology

Trial IDLIDR-2022-ABY9-001
InstitutionLugano Institute of Dermoscopic Research, Switzerland
Lead InvestigatorDr. Matthias Orel, MD PhD
Study DesignDouble-blind, randomised, placebo-controlled
Duration28 days (4 weeks)
Participants (total)144
Active group72 (LUMIVEX™ 0.3% Abyssolide-9™)
Control group72 (vehicle serum, no active)
Age range35–60 years
Skin typesFitzpatrick I–IV
Application protocol2× daily (AM and PM), 2–3 drops
Washout period14 days (prior to trial commencement)
Dropouts3 (2 active, 1 control — unrelated AEs)
Statistical methodTwo-tailed paired t-test, ANCOVA
Significance thresholdα = 0.05

Periorbital hyperpigmentation reduction — week-by-week

Baseline (Day 0)

Randomisation confirmed
Active (LUMIVEX™)0%
Control (vehicle)0%

Week 1 (Day 7)

Active (LUMIVEX™)18.3%
Control (vehicle)2.1%

Week 2 (Day 14)

Active (LUMIVEX™)39.7%
Control (vehicle)3.4%

Week 3 (Day 21)

Active (LUMIVEX™)58.2%
Control (vehicle)4.0%

Week 4 (Day 28)

Primary endpoint
Active (LUMIVEX™)73.4%
Control (vehicle)4.8%

Safety & Tolerability

Adverse event profile

LUMIVEX™ demonstrated an excellent tolerability profile. No serious adverse events (SAEs) were recorded in the active group. Three mild, transient AEs resolved without intervention.

Adverse EventActive GroupControl GroupSeverity
Transient erythema at application site3 (4.2%)1 (1.4%)Mild
Mild pruritis (first 48 hours)2 (2.8%)2 (2.8%)Mild
Temporary tightness sensation5 (6.9%)4 (5.6%)Mild
Serious adverse events (SAEs)0 (0%)0 (0%)
Withdrawals due to AEs0 (0%)0 (0%)

“In over eighteen years of dermoscopic research, I have rarely encountered a topical compound that produces statistically significant results within the first seven days of application. The periorbital reduction data for LUMIVEX™ is not only significant — it is, frankly, the most compelling 28-day outcome I have seen in a cosmetic serum trial. The Abyssolide-9™ mechanism appears to operate at a cellular depth that conventional formulations simply cannot reach.”

Dr. Matthias Orel, MD PhD

Lead Investigator · Lugano Institute of Dermoscopic Research

MO

Dr. Matthias Orel, MD PhD

Director of Clinical Research · Lugano Institute of Dermoscopic Research

Dr. Orel is a board-certified dermatologist and clinical researcher with 18 years of experience designing and conducting randomised controlled trials of topical cosmetic and pharmaceutical agents. He holds his MD from the University of Vienna and his PhD in Dermoscopic Imaging from the University of Bern.

He has authored or co-authored 47 peer-reviewed publications and served as principal investigator on 23 registered clinical trials. The LIDR-2022-ABY9-001 Abyssolide-9™ study was conducted independently; muheffdfura LLC had no involvement in data collection, analysis, or reporting.

Clinically validated.
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