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Accelerating Regulatory Submissions for Acne Treatment Efficacy and Tolerability

A dermatology-focused pharmaceutical company developed a novel topical gel formulation combining retinoid and anti-inflammatory agents for the treatment of mild to moderate acne vulgaris. The product was being positioned for launch in both regulated (U.S., EU) and semi-regulated markets with a goal of establishing strong clinical efficacy and a superior tolerability profile.

Client Challenges

  • Conduct a randomized, double-blind, placebo-controlled trial comparing new formulation vs. existing standards
  • Recruit a diverse adolescent and adult population with varying skin types and acne severity
  • Measure standardized lesion counts, Investigator Global Assessment (IGA), and subjective satisfaction scores
  • Capture photographic evidence, track adverse skin reactions, and ensure patient compliance with twice-daily use
  • Deliver regulatory-ready clinical data for submission to FDA, EMA, and ROW agencies

Clinvigilant Research Solution

Protocol & Endpoint Optimization

  • Designed a 12-week parallel-arm trial with 3 treatment groups
    (test, reference, placebo)
  • Defined endpoints aligned with FDA Acne Guidance for Industry (2005) and EMA CHMP guidance:
  • Primary: Mean % reduction in inflammatory and non-inflammatory lesion counts
  • Secondary: IGA score change, tolerability, subject satisfaction, quality of life (DLQI)

Site Activation & Participant Engagement

  • Activated 9 dermatology research sites across urban and suburban areas
  • Implemented pre-screening via digital acne assessment platform, increasing enrollment speed
  • Recruited 320 participants aged 12–35, stratified by Fitzpatrick skin types I–VI

Monitoring, Imaging & Data Integrity

  • Provided centralized monitoring with weekly QC reports for lesion count consistency
  • Integrated high-resolution photographic documentation into the CRF for third-party review
  • Captured investigator notes and global assessments at weeks 4, 8, and 12

Reporting & Regulatory Support

  • Delivered complete clinical study report (CSR) compliant with ICH E3
  • Prepared summary tables for Module 2.7.6 (Clinical Efficacy) for global submissions
  • Supported literature integration for combination therapy justification

Data Collection & Compliance Tracking

  • Used Clinvigilant’s eSource + eDiary platform to capture:
  • Daily self-application confirmations
  • Weekly side effect reporting (dryness, irritation, erythema)
  • Site-assessed lesion counts with photo capture tool
  • Employed automated reminders to increase adherence and site visit attendance

Outcomes

320

Subjects Enrolled

96.4%

Study Completion Rate

<4%

(mostly mild, self-resolving)

Local Irritation Reports

63% in active group vs. 28% placebo

Mean Lesion Count Reduction

2-grade improvement in 71% of active group

IGA Score Improvement

5 weeks post database lock

CSR + Regulatory Dossier Delivery

Client Testimonial

VP of Medical Affairs
Dermatology Biopharma Company

“This trial gave us the high-quality data we needed to differentiate our acne therapy in a crowded space. Clinvigilant’s dermatology expertise, digital tools, and data handling were first-class.”

Results?

Clinvigilant’s dermatology trial expertise, tech-enabled data collection, and agile study execution helped the sponsor rapidly generate credible clinical evidence for their acne treatment, while ensuring compliance with FDA, EMA, and global regulatory standards.

Ready to working with All-In-One CRO?

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

+44 1322 643254
+91 99130 11134
[email protected]

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