Protocol of The Clinical Evaluation

Volunteers

  • 26 men aged 18 to 70 years old
  • Brown to dark hair
  • Qualified for a grade 3 to 4 alopecia (Norwood scale)
  • With minimum 150 hair/cm2  and 40 telogen hairs/cm2

Protocol

  • Double blind clinical trial versus a placebo
  • Applying the formula once a day
  • 50% of volunteers received the placebo
  • 50% received the formula with 3% Redensyl®
  • Clinical study was performed under the control of a dermatologist.
  • Period of the test: autumn

Evaluated Parameters

Clinical Measures At D0, D30 And D84

  • Macro pictures on scalp
  • Density of hair in anagen phase
  • Density of hair in telogen phase
  • Ratio anagen/telogen
  • Pictures of the head
  • Self assessment questionnaire at D84

Notes

  • Shaving of a 1 cm2 area
  • Analysis on 0,7 cm2

Counting of Anagen (=growing) Hair

Protocol: Analysis on the volunteers’ scalp of the number of hair in anagen phase

! Slight non significant placebo effect up to D84 (activation of micro-circulation)
! Redensyl® stimulates by +9% hair in anagen phase

Counting of Telogen (=falling) Hair

Protocol: Analysis on the volunteers’ scalp of the number of hair in telogen phase

! Slight non significant placebo effect up to D84 (activation of micro-circulation)
! Redensyl® reduces hair in telogen phase by -17%

Follow Up of The Anagen/telogen Ratio

Protocol: Analysis on the volunteers’ scalp of the ratio of anagen versus telogen hair

! After 3 months, Redensyl® improves the ratio of anagen/telogen by +29%, reaching 2.37 from the initial 1.83

Pictures of Volunteers

Toxicological Evaluation

The toxicological evaluation on Redensyl® confirmed that the product has no side effects.

Safety test/ref Batch and Concentration tested Testing Facilities Study Number Results
Mutagenicity: Ames assay INDA-2014V1XMBS,
Ref: 13702_V1IMBS_140106
100%
IDEA lab 6.A6_5S- 20781-ID­-GLP (Appendix 1) Non-mutagenic
Skin irritation: Occlusive patch test/ According to the operational mode referenced PRM03-MO-­006 INDA-2014V1XMBS,
Ref: 13702_V1IMBS_140106
100%
Dermscan 14E0092- 1/GCP(Appendix 2) Non-irritating
Ocular irritation: Human cornea model test/ OECD guideline 405 INDA-2014V1XMBS,
Ref: 13702_V1IMBS_140106
100%
Idea lab 6.49-20768- ID14/00204/ GLP (Appendix 3) Non-irritating
Skin sensitization: HRIPT according Marzulli-Maibach Method INDA-2014V1XMBS,
Ref: 13702_V1IMBS_140106
100%
Dermscan DN-1332/14E009 3/GCP(Appendix 4) Non-irritating/Non-sensitizing
Biodegradability/ OECD guideline 301:1992 revised in 2006 section 3 part 1. INDA-2014V1XMBS,
Ref: 13702_V1XMBS_140106
20.5 mg/L
Eurofins S-2014- 00104Ami/ GLP(Appendix 5) Readily biodegradable