A Randomized Pilot Clinical Assessment Of Three Skincare Regimens On Skin Conditions In Infants

Abstract

Introduction: Few data are available on the comparison between the effects on infant skin of skin care products and those of water alone.

Patients and methods: In this single-center, evaluator-blind, parallel-group pilot study, healthy infants were randomized to near-daily washing for 12 weeks (starting in the summer and finishing in the winter months) with a mild liquid baby wash followed by use of baby lotion (wash+lotion), water followed by baby lotion (water+lotion), or water alone. Clinical and instrumental assessments of skin moisturization and barrier function were made.

Results: As expected the skin condition in all groups was affected by the change of the season. The skin of infants in all groups was mildly deteriorated (clinical grading) and with reduced moisture levels and increased barrier function. Instrumental measurements indicated that skin moisture and barrier function were better maintained in the wash+lotion and water+lotion groups than in the water-only group at week 12. Clinical assessment scores increased slightly over 12 weeks in all groups (P<0.05). At week 12, the wash+lotion group (n = 44) had significantly less change from baseline in overall skin condition and softness (lower scores) than did the water+lotion (n = 43) or water-only (n = 43) groups. The wash+lotion regimen maintained stable erythema and rash scores with lower mean values over time than in the other groups.

Conclusion: A regimen of a liquid baby wash and a baby skin lotion for 12 weeks resulted in less detrimental changes in instrumental and clinical measures of skin than using water and lotion or water alone.

Keywords: emollients; erythema; exanthema; infant; skin abnormalities.

Figure 1

Patient flow through the trial.

Figure 2

(A) Temperature and (B) humidity profile over the course of the study. Note: Blue lines indicate outside temperature and humidity and red lines indicate inside values.

Figure 3

Skin moisture. (A) Corneometer value over time and (B) change from baseline in Corneometer value. (C) Moisture Meter-D value over time and (D) change from baseline. Notes: ^aP<0.05 vs week 0, ^bP<0.05 vs week 6. *P<0.05. Color of asterisk over bar signifies the specific comparison made. Abbreviations: SEM, standard error of the mean; a.u., arbitrary units.

Figure 4

Skin barrier function. (A) TEWL over time and (B) Change in TEWL from baseline. Notes: ^aP<0.05 vs week 0, ^bP<0.05 vs week 6. Color of letters over lines signifies the specific comparison made. Abbreviation: SEM, standard error of the mean.

Figure 5

Skin pH and skin roughness. (A) Skin pH over time, (B) skin pH change from baseline, (C) skin roughness score (grey level, SkinEvidencePro) from images of forearm skin, and (D) skin roughness change from baseline. Notes: ^aP<0.05 vs week 0, ^bP<0.05 vs week 6. *P<0.05. Color of asterisk over bar signifies the specific comparison made. Abbreviation: SEM, standard error of the mean.

Figure 6

Overall skin condition. Dermatologist evaluation of overall skin condition score change from baseline (A). Parent/caregiver scores change from baseline (B). Comparison between dermatologist or parent scoring 0 at Week 0, 6 and 12 (C). Notes: *P< 0.05. Color of asterisk over bar signifies the specific comparison made. Abbreviation: SD, standard deviation.

Figure 7

Skin softness. Dermatologist evaluation of skin softness score change from baseline (A). Parent/caregiver scores change from baseline (B). Comparison between dermatologist or parent scoring 0 at Week 0, 6 and 12 (C). Notes: *P<0.05. Color of asterisk over bar signifies the specific comparison made. Abbreviation: SD, standard deviation.

Figure 8

Skin dryness. Dermatologist evaluation of skin dryness score change from baseline (A). Parent/caregiver scores change from baseline (B). Comparison between dermatologist or parent scoring 0 at Week 0, 6 and 12 (C). Note: *P<0.05. Color of asterisk over bar signifies the specific comparison made. Abbreviation: SD, standard deviation.

Figure 9

Redness/erythema. Dermatologist evaluation of redness/erythema score change from baseline (A). Parent/caregiver scores change from baseline (B). Comparison between dermatologist or parent scoring 0 at Week 0, 6 and 12 (C). Note: *P<0.05. Color of asterisk over bar signifies the specific comparison made. Abbreviation: SD, standard deviation.

Figure 10

Rash/irritation. Dermatologist evaluation of rash/irritation score change from baseline (A). Parent/caregiver scores change from baseline (B). Comparison between dermatologist or parent scoring 0 at Week 0, 6 and 12 (C). Note: *P<0.05. Color of asterisk over bar signifies the specific comparison made. Abbreviation: SD, standard deviation.

Figure 11

Tactile roughness. Dermatologist evaluation of tactile roughness score change from baseline (A). Parent/caregiver scores change from baseline (B). Comparison between dermatologist or parent scoring 0 at Week 0, 6 and 12 (C). Note: *P<0.05. Color of asterisk over bar signifies the specific comparison made. Abbreviation: SD, standard deviation.