Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Semi-occlusive Patch)

NCT01892657 Phase 4 COMPLETED Results posted

This study examined the possible sensitization and irritation effects of a moisturizer with sunscreen SPF 50+.

Details

Lead sponsor	Galderma R&D
Phase	Phase 4
Status	COMPLETED
Enrolment	128
Start date	2008-03
Completion	2008-08

Conditions

• Skin Irritation

Interventions

• Facial Moisturizer with SPF 50+

Primary outcomes

• Area of Erythema and Elevated Responses of Skin to Product — 3 consecutive weeks
  Subjects were patched 9 times at 48 hour to 72 hour intervals and graded for erythema and elevated responses (edema, papules, vesicles, bullae) on a 4 point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). 12 to 24 hours after the last patch application, a challenge patch was applied at the same site and a challenge patch was applied to an alternate site. Both were graded for the same criteria at 48 hours and at 96 hours. A total of 11 patches were applied to each subject. All patches were removed after 48 hours.

Countries

United States