MacDerma - AZA - McKinley Resources - Azelaic Acid

Identification & Functionality

Country of Origin: China
INCI Name: Azelaic Acid
Ingredient Origin: Synthetic
Cosmetic Ingredients Functions: Anti-Inflammatory,
Antioxidant,
Lightening Agent,
Whitening Agent
Technologies: Cosmetic Ingredients
Product Families: Cosmetic Ingredients — Cosmetic Actives
Skin Actives

Features & Benefits

Benefit Claims: Anti-Acne,
Anti-Bacterial,
Anti-Inflammatory,
Antioxidant Properties,
Blemish Control,
Redness Reduction,
Skin Lightening,
Solubilizing,
Whitening
Labeling Claims: 1,4-Dioxane-free,
Allergen-free,
Animal Products-free,
BSE-free,
Bisphenol A-free,
Butylated Hydroxyanisole-free,
CMR Substances-free,
Clean at Sephora,
Credo Clean Standard,
Formaldehyde-free,
Fragrance-free,
Gluten-free,
Glycol ether-free,
Hormones-free,
Latex-free,
Nanomaterials-free,
Nitrosamines-free,
Non-GMO,
Non-Phenolic,
Not Listed In California Proposition 65,
Not Tested on Animals,
Palm Oil-free,
Palm free,
Paraben-free,
Petrochemical-free,
Phthalates-free,
Silicone-free,
Soy-free,
Sulfate-free,
TSE-free,
Talc-free,
Ulta Beauty's Conscious Beauty

Applications & Uses

Markets: Personal Care
Applications: Personal Care — Beauty & Care
Bath & Shower,
Color Cosmetics,
Hair Care,
Skin Care,
Treatment Products
Application Format: Creams,
Leave On,
Lotions,
Rinse Off
Color Cosmetic Applications: Concealer,
Foundation
Hair Care Applications: Hair Conditioner,
Shampoos & Rinses
Skin Care Applications: Anti-Aging Products,
Astringent,
Body Firming Lotion,
Facial Cleanser,
Moisturizers,
Skin Toners
Treatment Product Applications: Acne Treatments,
Rosacea (Redness) Treatment
Use Level: 0.1

Properties

	Value	Units	Test Method / Conditions
Assay	min. 98.5	%	—
pH	4.0 - 5.0	—	—

	Value	Units	Test Method / Conditions
Azelaic Acid Content	100.0	%	—

	Value	Units	Test Method / Conditions
Heavy Metals	max. 10	ppm	—
Chlorides Content	max. 50	ppm	—

Regulatory & Compliance

Chemical Inventories: AICS (Australia),
DSL (Canada),
ECL (Korea),
EINECS (EU),
ENCS (Japan),
IECSC (China),
NZIoC (New Zealand),
PICCS (Phillipines),
TSCA (USA)

Technical Details & Test Data

Efficacy Testing Information: Efficacy End Point Azelaic Acid Foam 15% (N=483) VehicleOnly(N=478) Azelaic Acid Foam 15% (N=198)
VehicleOnly(N=203)

Mean Change in # of Inflammatory Lesions from Baseline -13.2 -10.3 -13.3 -9.5

IGA Success Rate % 32.1 23.4 43.4 32.5

IGA indicates Investigator's Global Assessment

Subjects with inflammatory papules and pustules (n=1362, ages 19-92) from 2 randomized, double-blind studies applied 15% Azelaic Acid foam or vehicle-only twice daily for 12 weeks

Result: Azelaic Acid Foam 15% demonstrated superior performance compared to vehicle only.

Effect of 20% Azelaic Acid Cream on Skin Lightening.

In-vivo testing of effect on melasma and other facial hyperpigmentation

Fifty-two darker-skinned patients clinically diagnosed with at least moderate melasma or other facial hyperpigmentation were treated with a 20% Azelaic Acid cream or vehicle-only for 24 weeks.

Pigmentary intensity was measured by a chromometer and by physician assessment.

Result: Overall, Azelaic Acid treatment resulted in a significant decrease in pigmentary intensity compared to vehicle-only (p=0.021)

Storage & Handling

Shelf Life: 3 years
Storage Conditions: Store in a cool, dry and well ventilated place in a tightly closed container.

MacDerma™ AZA

Efficacy End Point	Azelaic Acid Foam 15% (N=483)	VehicleOnly(N=478)	Azelaic Acid Foam 15% (N=198)	VehicleOnly(N=203)
Mean Change in # of Inflammatory Lesions from Baseline	-13.2	-10.3	-13.3	-9.5
IGA Success Rate %	32.1	23.4	43.4	32.5
IGA indicates Investigator's Global Assessment