APPENDIX 2

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Notes of Guidance

Appendix 2

Protocol for Anti-perspirant effectiveness assessment by direct comparison of products using gravimetric measurement under conditions of thermal stress – ‘The Clearcast protocol for testing comparative anti-perspirant claims’

Hot Room Conditions
a) Temperature: 102 +/- 4⁰F. Both to be uniform throughout room
b) Humidity: 37 +/- 7% RH

Measurement of Perspiration
a) 40 minute hot room warm up period before collections
b) Two successive 20 minute sweat collections in each 40 minute test period, the mean value to be used in computing the results
c) Pads should absorb all moisture and remain intact. Webril andRaytex pads should satisfy this condition

Panel Selection
Generally – All female

  • Age 18+
  • Healthy – not pregnant
  • Axillae shaved 3 days before text commences
  • Should produce >/= 100mg sweat per untreated axilla per 20 minute period under hot conditions
  • In the event of the need for an all-male panel, axillae will beunshaved

Panel
Approximately 50 for any individual test

Panel Control
a) Panellists time in the hot room should be under conditions which exclude extraneous factors affecting results e.g. no smoking, or drinking in the hot room. Panellists sit upright, legs uncrossed. Clothing should be comfortable and permit easy access to axillae. Panellists should relax before sitting.
b) For a period of 30 days before water only*
c) Panellists to acclimatise for not less than 40 minutes after product application before entering hot room

Product Form
As marketed. Packs should not be less than 20% full at end of test

Product Application
a) Application controlled and made by supervisor and amount applied recorded
b) Amount should be in line with consumer habits – mean amount +/- 10%for both

  • Aerosols – 2 second spray
  • Roll-ons – 300mg

Hot room Regime
a) Results must relate to product application and not be affected by biological variability or test-induced constraints. Any bias due to assigning products to left or right axillae must be demonstrably insignificant. The left/right ratio should be directly determined on dayone of each test by sweat stimulations and collection before the anti-perspirant is applied.
b) Single applications on each of five successive days
c) Results of each test to be computed from the amount of sweat collected on day 5
d) There shall not be less than 30 days between tests for each panellistto ensure the absence of residual effects from previous tests

Assessment of Results
For an individual test:
a) At least a measured, statistically significant (p<0.905) 20% difference in sweat output between treated an control axillae will be required in order to conclude significant sweat reduction at the treated site. 95% confidence levels should also be given
b) Significance of results: p null value < / - 0.05 error variance < / - 0.08

It has been suggested that, for the convenience of panellists, a relaxation has been contemplated which permits prospective panellists to wash under arm with 1ml liquid soap in the pre-test period.