Submit RFI

Demonstrating the Efficacy of a Scalp/Hair Treatment Through a Controlled Clinical Study

A premium cosmeceutical brand launched a new topical hair and scalp treatment targeting androgenic alopecia and scalp inflammation. With growing demand for clinically backed beauty and wellness products, the brand aimed to substantiate its efficacy claims through a controlled clinical trial in support of both consumer trust and regulatory defensibility.

Client Challenges

  • Design a dermatologist-supervised, placebo-controlled clinical trial for a cosmetic-grade formulation
  • Validate improvement in hair density, scalp condition, and user satisfaction
  • Implement standardized scalp imaging and digital hair counts
  • Ensure high compliance, especially in a home-use setting
  • Generate data suitable for marketing claims, dermatologist endorsements, and global retail launch

Clinvigilant Research Solution

Protocol Development & Clinical Design

  • Designed a 16-week, randomized, investigator-blinded study
  • Primary endpoints included:
  • Change in hair count per cm² (via dermoscopy)
  • Reduction in scalp redness, scaling, and oiliness (graded scores)
  • Secondary endpoints:
  • Subject-reported hair quality and confidence scores
  • Photographic improvement grading by blinded dermatologists

Site Engagement & Dermatology Network

  • Activated 4 top-tier dermatology clinics with experience in hair & scalp studies
  • Provided clinicians with digital trichoscopy tools for consistent imaging
  • Recruited 120 subjects (men and women, ages 25–55) with self-reported hair thinning or scalp issues

Data Capture, Analysis & Blinded Review

  • Used a central image review panel to assess hair density changes and before/after comparisons
  • Captured investigator-assessed scores for inflammation and scalp condition
  • Collected participant satisfaction surveys on usability, fragrance, texture, and perceived benefits

Home-Use Monitoring & Compliance

  • Delivered study kits with scalp treatment product, application guides, and compliance diaries
  • Captured PROMs (e.g., Foot and Ankle Ability Measure) via ePRO on tablet at clinics
  • Sent automated SMS/email reminders for twice-daily use

Results Reporting & Claim Support

  • Created a clinical study summary report for marketing and regulatory use
  • Provided claim substantiation data for packaging, website, and advertising approval
  • Delivered optional scientific poster and abstract for industry conferences

Outcomes

120

Subjects Enrolled

98%

Study Completion Rate

4 weeks post last visit

Time to Final Data Report

+21 hairs/cm² vs. baseline

Mean Hair Count Increase

4.6 / 5

User Satisfaction
(Overall Score)

2-grade improvement in 68% of participants

Scalp Inflammation Score Reduction

Client Testimonial

Head of R&D
Global Cosmeceutical Brand

“We wanted a scientific edge in a beauty market full of bold claims. Clinvigilant gave us credibility, clean data, and a compelling story for dermatologists and consumers alike.”

Value Delivered

Clinvigilant Research’s seamless management of this cosmetic clinical trial delivered robust, photodocumented results—empowering the brand to confidently promote its scalp and hair care solution with real clinical proof across digital, retail, and professional channels.

Ready to working with All-In-One CRO?

Together, We Accelerate Breakthroughs – Bringing New Treatments to Patients Faster