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A Data-Driven Clinical Study Design for Acne Management Formulations, Integrating Dermatological Gradings, Instrumental Assessments, and Participant-Reported Outcomes
Conference
Session 1: Hormones influence on Skin & Hair
Day 1
9:50 am
Background: Through methodologically sound, ethically governed clinical trials aligned with regulatory
frameworks, the selection of research methodology plays pivotal role in scientific validation and claim substantiation of acne management formulations. By merging dermatological grading scales with advanced instrumental techniques, right methodology ensures a comprehensive evaluation of parameters.
Materials and Methods: Dermatological assessment techniques, viz. Acne lesions count of
inflammatory (papules and pustules) and non-inflammatory (blackheads and whiteheads) lesions; skin redness (erythema), pigmentation; skin roughness and dryness; skin radiance; and facial pores assessment are proven methods for clinical assessments. Advanced instrumental assessment techniques include skin brightness, sebum level measurement, skin hydration, Transepidermal Water Loss, post-inflammatory hyperpigmentation (PIH) spot size, along with the image analysis equipment
that quantifies skin texture, changes in severity of acne lesions and scars with precise depth and area
measurements, skin pigmentation and redness, pore visibility etc. that provides instant, reproducible results. A structured self assessment questionnaire further adds value. A randomized, parallel group, assessor-blinded, comparative study was designed for assessment of efficacy and safety of two topical formulae on 92 healthy adult participants with mild to moderate acne, over a 4-week treatment period
with a 2-week relapse follow-up.
Results: Both the test products demonstrated significant reductions in total acne lesion count.
Improvements were observed in acne severity, redness, elevation, and PIH intensity and size. Skin brightness and radiance improved significantly, with increased L* and dE94 values on cheeks and
forehead. Sebum levels and excretion rates decreased consistently, while hydration level was
significantly increased. TEWL values reduced, indicating enhanced skin barrier function. Sebaceous pore parameters - count, volume, porosity index, density, and depth exhibited marked improvement.
Conclusions: Both topical formulae demonstrated comprehensive efficacy and safety in managing
acne-related imperfections. They delivered sustained benefits post-treatment and are well-suited as
cosmetic interventions for acne-prone skin, supported by clinical, instrumental and subjective
evidence.
Dr. Simran Sethi
Cliantha Research
Dr. Simran Sethi is the Senior Director at Cliantha Research, where she has been a key scientific and
clinical leader since 2006. A clinician and she bring over 20 years of expertise across Clinical Research,
Medical Affairs, and Phase I–IV clinical development. As Principal Investigator, Dr. Sethi has overseen
more than 2,000 pharmacokinetic studies. Her core strengths include the design and execution of clinical
trials in skin blanching, nutraceuticals, cosmetics and dermatology. She is a respected speaker in clinical
trial conferences and GCP workshops where she is known for her clarity, scientific rigor, and deep
domain knowledge.
Cliantha Research is a leading full-service Clinical Research Organization (CRO) committed to
delivering high-quality, scientifically robust solutions for global pharmaceutical, biotechnology,
and cosmetic companies. With expertise spanning Clinical Trials (Phase I–IV),
Bioavailability/Bioequivalence studies, Dermatology research, and Consumer Healthcare, Cliantha ensures compliance with international regulatory standards. With global presence in India, the U.S., and Canada, Cliantha conducts high-quality trials across pharmaceuticals,
biologics, cosmetics, personal care, and nutraceuticals in safety and efficacy segment. The
organization integrates advanced technologies and ethical practices to provide end-to-end
services. Its multidisciplinary team of experienced professionals focuses on innovation,
accuracy, and timely execution, making Cliantha a trusted partner for scientific innovations and claim substantiation. Ensuring applicable regulatory compliance with Good Clinical Practices (GCP), Cliantha combines scientific rigor with operational excellence to support clients in achieving regulatory approvals and market success.
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