Cetaphil RestoraDerm Moisturizer

Cetaphil RestoraDerm Moisturizer is a skin barrier repair lotion that contains a ceramide precursor and components of the skin's natural moisturizing factors, designed to help normalize the compromised skin barrier seen in individuals with eczema.

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Effects


Grade Level of Evidence
A Double-blind, controlled study with more than 50 participants.
B Controlled study that is single-blind or has less than 50 participants.
C Controlled or comparative study.
D Uncontrolled or observational study.
Grade Effect Size of Effect Comments

B

Increased skin hydration

Strong

More than doubles the moisturization level of the stratum corneum after just 4 weeks' of use.

B

Enhanced barrier function

Strong

Causes transepidermal water loss (TEWL) to decline by 30% over 4 weeks, indicative of a strengthened skin barrier.

B

Dermatitis treatment

Moderate

Improves atopic dermatitis by restoring the integrity of the stratum corneum and increasing the contents of the natural moisturizing factors in the skin.

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Ingredients


Water, Glycerin, Caprylic/Capric Triglyceride, Helianthus Annus (Sunflower) Seed Oil, Pentylene Glycol, Butyrospermum Parkii (Shea Butter), Sorbitol, Cyclopentasiloxane, Cetearyl Alcohol, Behenyl Alcohol, Glyceryl Stearate, Tocopheryl Acetate, Hydroxypalmitoyl Sphinganine, Niacinamide, Allantoin, Panthenol, Arginine, Disodium Ethylene Dicocamide PEG-15 Disulfate, Glyceryl Stearate Citrate, Sodium PCA, Ceteareth-20, Sodium Polyacrylate, Caprylyl Glycol, Citric Acid, Dimethiconol, Disodium EDTA, Sodium Hyaluronate, Cetyl Alcohol.
NAME ANTIOXIDANT UV PROTECTION COMEDOGENIC IRRITANT SAFETY
AQUA (SOLVENT) 0 0 ALLOWED (SOURCE)
GLYCERIN (DENATURANT, HUMECTANT, PERFUMING, SOLVENT) 0 (SEE SOURCES) 0 (SEE SOURCES) ALLOWED (SOURCE)
CAPRYLIC/CAPRIC TRIGLYCERIDE (EMOLLIENT, MASKING, PERFUMING, SKIN CONDITIONING, SOLVENT) NO DATA NO DATA ALLOWED (SOURCE)
HELIANTHUS ANNUUS SEED OIL (EMOLLIENT, MASKING, SKIN CONDITIONING) 0 (SEE SOURCES) 0 (SEE SOURCES) ALLOWED (SOURCE)
PENTYLENE GLYCOL (SKIN CONDITIONING, SOLVENT) NO DATA NO DATA ALLOWED (SOURCE)
BUTYROSPERMUM PARKII BUTTER (SKIN CONDITIONING, VISCOSITY CONTROLLING) NO DATA NO DATA ALLOWED (SOURCE)
SORBITOL (HUMECTANT, PLASTICISER, SKIN CONDITIONING) 0 (SEE SOURCES) 0 (SEE SOURCES) ALLOWED (SOURCE)
CYCLOPENTASILOXANE (EMOLLIENT, HAIR CONDITIONING, SKIN CONDITIONING, SOLVENT) NO DATA NO DATA ALLOWED (SOURCE)
CETEARYL ALCOHOL (EMOLLIENT, EMULSIFYING, EMULSION STABILISING, FOAM BOOSTING, OPACIFYING, SURFACTANT, VISCOSITY CONTROLLING) 2 (SEE SOURCES) 1 (SEE SOURCES) ALLOWED (SOURCE)
BEHENYL ALCOHOL (BINDING, EMOLLIENT, EMULSION STABILISING, VISCOSITY CONTROLLING) NO DATA NO DATA ALLOWED (SOURCE)
GLYCERYL STEARATE (EMOLLIENT, EMULSIFYING) 2 (SEE SOURCES) NO DATA ALLOWED (SOURCE)
TOCOPHERYL ACETATE (ANTIOXIDANT, SKIN CONDITIONING) 0 (SEE SOURCES) 0 (SEE SOURCES) ALLOWED (SOURCE)
HYDROXYPALMITOYL SPHINGANINE (HAIR CONDITIONING, SKIN CONDITIONING) NO DATA NO DATA ALLOWED (SOURCE)
NIACINAMIDE (SMOOTHING) NO DATA NO DATA ALLOWED (SOURCE)
ALLANTOIN (SKIN CONDITIONING, SKIN PROTECTING, SOOTHING) 0 (SEE SOURCES) 0 (SEE SOURCES) ALLOWED (SOURCE)
PANTHENOL (ANTISTATIC, HAIR CONDITIONING, SKIN CONDITIONING) 0 (SEE SOURCES) 0 (SEE SOURCES) ALLOWED (SOURCE)
ARGININE (ANTISTATIC, HAIR CONDITIONING, MASKING, SKIN CONDITIONING) NO DATA NO DATA ALLOWED (SOURCE)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (CLEANSING, FOAM BOOSTING, HAIR CONDITIONING, SURFACTANT) NO DATA NO DATA ALLOWED (SOURCE)
GLYCERYL STEARATE CITRATE (EMOLLIENT, EMULSIFYING, SKIN CONDITIONING) NO DATA NO DATA ALLOWED (SOURCE)
SODIUM PCA (ANTISTATIC, HAIR CONDITIONING, HUMECTANT, SKIN CONDITIONING) 0 (SEE SOURCES) 0 (SEE SOURCES) ALLOWED (SOURCE)
CETEARETH-20 (CLEANSING, EMULSIFYING, SURFACTANT) 2 (SEE SOURCES) 3 (SEE SOURCES) ALLOWED (SOURCE)
SODIUM POLYACRYLATE (ABSORBENT, BINDING, EMOLLIENT, EMULSION STABILISING, FILM FORMING, HAIR FIXING, SKIN CONDITIONING, VISCOSITY CONTROLLING) NO DATA NO DATA ALLOWED (SOURCE)
CAPRYLYL GLYCOL (EMOLLIENT, HAIR CONDITIONING, SKIN CONDITIONING) NO DATA NO DATA ALLOWED (SOURCE)
CITRIC ACID (BUFFERING, CHELATING, MASKING) NO DATA NO DATA ALLOWED (SOURCE)
DIMETHICONOL (ANTIFOAMING, EMOLLIENT, MOISTURISING) NO DATA NO DATA ALLOWED (SOURCE)
DISODIUM EDTA (CHELATING, VISCOSITY CONTROLLING) NO DATA NO DATA ALLOWED (SOURCE)
SODIUM HYALURONATE (HUMECTANT, SKIN CONDITIONING) 0 (SEE SOURCES) 0 (SEE SOURCES) ALLOWED (SOURCE)
CETYL ALCOHOL (EMOLLIENT, EMULSIFYING, EMULSION STABILISING, FOAM BOOSTING, MASKING, OPACIFYING, SURFACTANT, VISCOSITY CONTROLLING) 3 (SEE SOURCES) 2 (SEE SOURCES) ALLOWED (SOURCE)

Clinical Studies


Improvement of skin barrier function in atopic dermatitis patients with a new moisturizer containing a ceramide precursor.

Products

Cetaphil RestoraDerm Body Moisturizer

Trial Design

Randomized, double-blind, single-center, controlled

Duration

28 days of treatment

Subjects

20 men and women aged at least 18 years who had controlled atopic dermatitis (no active lesions in the target area) and clinically xerotic skin

Regimen

Subjects applied Cetaphil RestoraDerm Body Moisturizer twice daily to 1 leg, leaving the other leg untreated

Methods of Assessment

Measurements of transepidermal water loss using a DermaLab

Measurements of skin hydration using a Corneometer

Clinical evaluation of skin dryness on a 5-point scale

Measurements of stratum corneum thickness, total water, NMF, PCA and ceramide contents via Raman spectroscopy

Side Effects

No related adverse events were reported.

Conflicts of Interest

Of the 5 study authors, 2 were employees of Galderma, 1 was a consultant for the company, and the remaining 2 received investigator fees for the study.

Effects observed in this study:

At the beginning of the study, the areas designated to be treated or untreated had similar clinical scores of skin dryness, skin hydration and TEWL. After 4 weeks of treatment, TEWL was observed to be significantly more reduced (-30% versus -4%) from baseline in the area treated with the Cetaphil RestoraDerm Moisturizer. Significantly increased stratum corneum hydration was correspondingly measured (118% versus 25%) from baseline for the Cetaphil RestoraDerm Moisturizer-treated and untreated areas respectively. Clinical grading of dryness also revealed a significantly superior improvement for the Cetaphil RestoraDerm Moisturizer-treated area (-56%) compared to the untreated area (-22%).

Furthermore, Raman spectroscopy showed a significantly higher level of ceramide content in the Cetaphil RestoraDerm Moisturizer-treated area at both superficial (5 µm from the skin surface) and deeper layers (10 µm from the skin surface) of the stratum corneum. NMF, PCA and the water levels measured were also numerically higher for the Cetaphil RestoraDerm Moisturizer-treated area, but these did not reach statistical significance.

Safety and tolerability of a body wash and moisturizer when applied to infants and toddlers with a history of atopic dermatitis: results from an open-label study.

Products

Cetaphil Restoraderm Skin Restoring Body Wash

Cetaphil Restoraderm Skin Restoring Moisturizer

Trial Design

Single-center, open-label

Duration

4 weeks of treatment

Subjects

53 boys and girls aged 3-36 months with atopic dermatitis

Regimen

The parent or guardian of each subject applied the test products at least once daily to the generalized skin surface and as often as needed for localized cleansing and moisturizing. They were also counseled not to exceed 2 full body washes in a single day.

Methods of Assessment

Clinical evaluations of erythema, edema, dryness, scaling, rash and signs of discomfort upon application

Subjects' parents or legal guardians completed assessment questionnaires for each product regarding their attributes at the final study visit

Corneometer measurements of stratum corneum moisture content via the electrical capacitance method

Measurements of transepidermal water loss (TEWL) using a Tewameter TM300

Side Effects

19 subjects experienced at least 1 adverse event during the study. Of the 37 reported adverse events, 25 were determined to be definitely unrelated to the test products, 5 were unlikely to be related, 3 were possibly related, 2 were probably related and 1 was definitely related. The events that were probably or definitely related to the use of the test products were stinging burning in the eyes, and scalp itch, while the events that were probably related included a break out on the face, worsening of atopic dermatitis, and full body rash.

2 subjects were withdrawn because of adverse events (1 for erythema, marked scaling on the face, worsening of AD, and impetigo, 1 for body rash).

Conflicts of Interest

Galderma Laboratories provided funding for the study.

Effects observed in this study:

To evaluate the tolerability of the Cetaphil RestoraDerm products, the worst post-baseline local tolerability scores were averaged for each parameter. A score of 0 was considered a success, and a score of 1 or greater was considered a failure. For erythema and scaling and dryness, the percentage of success was higher after product use, whereas there was little change for edema.

TEWL measurements showed that there was a statistically significant decrease starting from week 2 which persisted to the end of the study, while corneometry results indicated that skin hydration of the dorsal forearm and the lower leg increased by statistically significant amounts over the same time period.

Finally, the majority of the patients' parents and legal guardians found the Cetaphil products pleasant or very pleasant, that their child's skin was better protected as compared to their usual products and that they would like to continue using them.