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Tolerability of a Foaming Facial Cleanser and Moisturizer SPF 30 in a Pediatric Population (7-11) With Acne Prone Skin.
The purpose of this study is to determine the tolerability of Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30 in pediatric subjects (7-11) with acne prone skin.
Details
| Lead sponsor | Galderma R&D |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 35 |
| Start date | 2013-05 |
| Completion | 2013-06 |
Conditions
- Acne Prone Skin
Interventions
- Facial Cleanser and Moisturizer SPF 30
Primary outcomes
- Cutaneous Tolerability Based on Visual Inspection - Erythema — Week 3
Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Erythema: 0 = none, no observable redness; 1 = very mild, slight redness, spotty or diffuse; 2 = mild, moderate redness; 3 = moderate, intense; 4 = severe, fiery red with edema. - Cutaneous Tolerability Based on Visual Inspection - Edema — Week 3
Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Edema: 0 = none; 1 = mild; 2 = moderate; 3 = intense. - Cutaneous Tolerability Based on Visual Inspection - Dryness — Week 3
Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Dryness: 0 = no observable scaling; 1 = fine flakes/scaling; 2 = moderate flakes/scaling; 3 = larger flakes/severe scaling. - Cutaneous Tolerability Based on Visual Inspection - Roughness — Week 3
Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Roughness: 1 - no roughness, skin is fine, silky smooth, 2 - firm (not too rough, not too smooth), 3 - coarse, rough skin, 4 - leathery, flaky skin.
Countries
United States