Mintop Pro+ Study Blueprint

Protocol: PRO-TE-IND-001 (Illustrative)  |  Status: Draft  |  Prepared for: Mintop Pro+ Team
🎯

The Strategy

Pivot from subjective "Consumer Perception" to objective "Clinical Phototrichogram" data.

🧪

The Science

Reframe "10-in-1" as "Synergistic Modulation": vascular, anchorage, and growth pathways.

🛡️

The Safety

Open-label, single-arm design to establish efficacy without the risk of formal head-to-head failure.

Study Protocol Summary

Primary Objective: Evaluate the efficacy of Mintop Pro+ in improving the Anagen/Telogen (A/T) Ratio from baseline to Week 16.
Parameter Detail
Study Design Prospective, open-label, multi-center, real-world evidence (RWE) study
Sample Size N = 90 (targeting ~72 completers)
Duration 16 weeks (4 visits)
Population Adults (18–55 years) with Telogen Effluvium (acute or chronic)
Technology Phototrichogram (TrichoScanÂŽ / CASLite-Nova)

Endpoints

Case Report Form (CRF) Design

Key data fields to ensure publication-quality evidence.

1. Baseline Visit (Day 0)

The "Pull Test":
Grasp 50–60 hairs and apply gentle traction.
Positive (shedding) criterion: > 6 hairs extracted.

2. Phototrichogram Analysis

To be recorded at Week 0, Week 8, and Week 16.

Field ID Parameter Unit
IMG_01 Total ROI area cm²
DATA_01 Anagen hair count (growing) Count
DATA_02 Telogen hair count (resting) Count
CALC_01 A/T ratio Ratio

Patient Communication (ICF)

⚠️ Crucial conversation: explaining the "micro-trim" requirement for phototrichogram.

To get scientific data, investigators must explain the phototrichogram procedure clearly.

Script for Investigators

“To prove the serum works, we cannot just guess. We need to take a microscopic picture of your hair roots. To do this, we trim a tiny spot—about the size of a small coin—down to around 1 mm. It is easily hidden by your other hair, but it allows us to count the ‘growing hairs’ versus the ‘resting hairs’ accurately.”

Timeline

Week 0: Screening, pull test, and first phototrichogram
Week 4: Safety check and refill
Week 8: Interim phototrichogram assessment
Week 16: Final phototrichogram and satisfaction survey

The Competitive Landscape

The Threat: Bontress Pro+

  • Evidence: Phototrichogram-based data
  • Claims: “12,000 new hairs”
  • Status: Currently perceived as scientifically superior

The Opportunity: Mintop Pro+

  • Current position: Consumer survey–driven, subjective evidence
  • Goal: RWE study with objective phototrichogram endpoints
  • Strategic win: “Comprehensive multi-pathway modulation” story