Why this page exists

Most lash and hair products are sold on before-and-after photographs. MD® was built the other way round — the formulation came first, then the studies, and the marketing had to live within what the studies actually found.

That record now spans nearly twenty years: a randomized, double-blind, placebo-controlled clinical trial published in a PubMed-indexed journal; two Institutional Review Board–reviewed ocular safety studies conducted under board-certified ophthalmologist supervision; a repeat insult patch test in 209 subjects; genotoxicity, cytotoxicity and sensitization assays run under FDA Good Laboratory Practice; a European Cosmetic Product Safety Report; and independent consumer-use studies at accredited laboratories in Montreal and Brazil.

Everything below names the laboratory, the study number, the population and the date. Where a study measured something, we say what it measured. Where it did not, we say that too.

MD® is developed by Dr. Susan Lin, M.D. — board-certified in Obstetrics & Gynecology and Anti-Aging Medicine, in clinical practice for more than 35 years, and the inventor named on U.S. Patent 8,206,695, in force to 22 February 2031, and on the corresponding granted Chinese patents ZL 200810094338.2 and ZL 201110061008.5. See the full intellectual property register.

The study register

Every study in the MD® substantiation file, with the laboratory and the population that generated it.

The AppTec toxicology memorandum (reference 200089, Randy D. White, Ph.D., 1 May 2008) is the bridge document that ties the laboratory test-article designations to the branded product, and is held with the study reports.

Published peer-reviewed research

Choy I, Lin S. Eyelash enhancement properties of topical dechloro ethylcloprostenolamide. Journal of Cosmetic and Laser Therapy. 2008;10(1):1–4. DOI 10.1080/14764170802054138. PMID 18569264.

A randomized, double-blind, placebo-controlled trial in 34 healthy volunteers. The study used a split-eye design: every subject applied full-strength product to one eye, while the other eye received half-strength, quarter-strength or placebo. Lash length was measured with microcalipers to 0.1 mm at six locations per eye, by technicians blinded to treatment assignment, and analysed by paired two-tailed Student's t-test.

What it found

After four weeks of nightly use, eyelash length increased by 42% to 53% across the active groups, against 20% for placebo. The difference was statistically significant. All patients reported an improved appearance in the length of their lashes. Twenty-one patients who continued daily use were followed to four months, at which point mean lash length increase approached 80% from baseline.

What it did not find

Thickness and density were not measured endpoints. Twenty-four percent of subjects reported increased thickness or fullness subjectively, and we report it as that — a subjective observation, not a measurement.

What was reported as an adverse event

Fifteen of 34 patients reported mild or minimal irritation. It was transient and typically resolved within a few days of continued use. One patient reported moderate irritation and discontinued. No iris pigmentation change, no periocular skin darkening and no discoloration were observed.

We publish that number because it is the honest answer to the question customers actually ask. It is also why the instruction on the carton is one stroke along the upper lash line, and no more.

Related reading: Is your eyelash serum safe? A physician's guide to reading lash conditioner labels · 6 facts and myths about lash growth serums · MD Lash Factor® Eyelash Conditioner

Ocular safety

A product applied to the lash line every night has to be examined by an ophthalmologist, not a marketing department. Both MD lash formulations have been.

CRL93007A — the original formulation

Conducted at Clinical Research Laboratories, Inc. in Piscataway, New Jersey, under a protocol reviewed by the Allendale Investigational Review Board in accordance with 21 CFR Parts 50 and 56. The IRB approved the protocol, the informed consent form, the recruitment materials, the written instructions and the ingredient listings before initiation. A Good Clinical Practice quality assurance audit was performed against the source documents and raw data.

Thirty-five female subjects aged 19 to 64 were enrolled — 11 with normal eyes who did not wear contact lenses, 12 normal-eye contact lens wearers, and 12 with self-assessed sensitive eyes. Thirty completed. Five discontinued for reasons unrelated to the test material. Examinations were performed by Bruce E. Kanengiser, M.D., a Diplomate of the American Board of Ophthalmology, and Yang Gao, M.D.

What the examinations showed

• No clinically significant change in intraocular pressure, visual acuity, or tear film break-up time at the final examination
• No corneal abnormalities or superficial punctate keratopathy on slit lamp biomicroscopy
• No increases in subjective irritation, lacrimation, eyelid inflammation or bulbar conjunctival irritation
• No changes in contact lens colour, scratches or deposits
• No adverse experiences reported

Intraocular pressure is the endpoint that matters most for any product in this category, and it is the one most competitors do not publish. Three subjects showed trace palpebral conjunctival inflammation, which the investigator judged unrelated to the test material and attributed to hair products, mechanical factors, contact lens wear, sensitive-eye status or seasonal factors. We report that rather than claim a clean sweep.

CRL32009 — the prostaglandin-free formulation

The same laboratory, the same IRB and the same investigators repeated the design on the prostaglandin-free formulation between 21 April and 19 May 2009. Thirty-three subjects aged 19 to 65 were enrolled across the same three groups; 32 completed. The conclusion was the same: no potential for eliciting ophthalmic irritation, no corneal abnormalities, and no changes in contact lens colour, scratches or deposits.

Four subjects recorded slight-to-moderate transient burning or stinging in their daily diaries, lasting from seconds to about five minutes. All four completed the study without any change to their schedule and with no increase in measured irritation.

Read the detail: Lash clinical evidence · Lash & brow anatomy

Dermal safety — 209 subjects

The largest single study in the MD® file is a human repeat insult patch test in 209 subjects — 149 women and 60 men — conducted at Clinical Research Laboratories, Inc.

A repeat insult patch test is the standard method for establishing whether a topical product irritates skin on repeated exposure, or sensitises it so that a later exposure provokes an allergic response. The protocol used nine induction applications, followed by a two-week rest period, followed by a challenge application to a previously untreated site.

Result: no clinically significant potential for dermal irritation or sensitization.

Two hundred and nine subjects is an unusually large panel for a cosmetic patch test. The conventional standard is 50 to 100. We ran it at that scale because the product is applied to the thinnest, most permeable skin on the body, every night, indefinitely.

The prostaglandin-free formulation was separately tested at AMA Laboratories, Inc. in New City, New York: a semi-occlusive repeat insult patch test in 52 enrolled subjects aged 19 to 68, of whom 50 completed. The study report records that no adverse reactions of any kind were noted during the course of this study, and concludes that the material is a non-primary irritant and non-primary sensitizer. It was signed by the Study Director, a consulting dermatologist and the Technical Director.

Toxicology under Good Laboratory Practice

Three independent assays were run at AppTec Laboratory Services in 2007, before the product reached the market.

All test and study materials have been voluntarily submitted to the U.S. Food and Drug Administration, and MD® manufacturing and distribution facilities have been FDA-inspected. MD® products are cosmetics. They are not FDA-approved or FDA-cleared, and no endorsement by any agency is claimed or implied.

European safety assessment

A Cosmetic Product Safety Report was completed by Innovant Research in Newbury, United Kingdom, under Regulation (EC) No. 1223/2009, applying the SCCS Notes of Guidance and the GLP principles set out in Council Directive 2004/10/EC.

The assessor's conclusion was that all ingredients, individually and in combination, carry an adequate Margin of Safety — that is, greater than 100. The product was found to be stable and appropriately preserved.

A point of accuracy that is often blurred in this industry: cosmetics are not approved in the European Union. There is no pre-market authorisation. A Cosmetic Product Safety Report is the assessor's documented conclusion that a product is safe for its intended use, and it is the document a Responsible Person must hold before placing a product on the EU market. We describe it as exactly that and nothing more.

Independent consumer-use studies

Alongside the clinical and safety work, three independent laboratories have run consumer-use and in-use evaluations. Where an evaluation records only what people report, we label it as that. Where an instrumental assessment was performed, we say so.

Brow — Spincontrol North America, 56 days

Conducted at Spincontrol North America Inc. in Montreal, a subsidiary of Spincontrol Laboratory in Tours, France, which holds an operating licence from AFSSAPS, the French health products safety agency, and is certified to ISO 9001 / AFAQ. Protocol XX-MV01-WT-AT10, Lead Investigator Patrick Beau, Ph.D., with Scientific Director Francis Vial, Ph.D. and biostatistician Valérie Breton. Twenty-three subjects, evaluated at 56 days, analysed by chi-square at the 5% threshold.

Significant agreement was recorded for: eyebrows seem thicker (78%), look better (83%), seem healthier (87%), seem more hydrated (87%), seem more conditioned (78%), the product does not irritate eyes or skin (87%), and the product is easy to apply (96%).

Agreement did not reach significance for: brows look fuller, seem darker, seem more numerous, seem longer, or look younger. We report the second list as well as the first. The statistical test compares agreement against disagreement within a single group — it is not a comparison against placebo, and density was not measured instrumentally.

Hair — Spincontrol, 17 weeks

An independent 17-week study at Spincontrol North America in which hair density was assessed by photographic analysis. Alongside the instrumental assessment, seventy-one percent of subjects reported an improvement in the appearance of their hair, and 75% said they would recommend the product.

Scalp — Medcin Instituto da Pele

A 50-subject repeat insult patch test conducted in accordance with Good Clinical Practice and the Declaration of Helsinki. No sensitisation was observed under study conditions.

Related reading: Top 5 tips if you're losing your eyebrows · Common causes of female hair loss · Women's hair loss knowledge centre

Evidence by category

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Citation format & document availability

References on these pages follow APA 7th edition format. Where original sources are publicly available — peer-reviewed journals, patent databases — direct links are provided. Where studies are proprietary or contain subject-identifying information, summaries are provided with an availability statement.

Full study reports, protocols and data not included in these public summaries are available to qualified industry partners, healthcare professionals, journalists and regulatory bodies on request. Contact MD® with your inquiry.

Questions about any specific claim are answered in the MD® FAQ.

About the author

Dr. Susan Lin, M.D. is a board-certified physician in Obstetrics & Gynecology and Anti-Aging Medicine, with more than 35 years of clinical practice. She trained at Boston University School of Medicine as an NIH Scholar, with clinical fellowship at Memorial Sloan Kettering and MD Anderson, and held an appointment as Assistant Clinical Professor at UCSF School of Medicine.

She is the founder of La Canada Ventures, Inc.; the inventor named on the granted United States and Chinese patents covering the MD Lash Factor® eyelash composition; and lead author on the peer-reviewed clinical study published in the Journal of Cosmetic and Laser Therapy in 2008. She authored the chapters on eyelash anatomy and conditioners and on skin rejuvenation in Harry's Cosmeticology, 9th Edition. She serves as an Expert Reviewer for the Medical Board of California and has been appointed to the U.S. Department of Commerce District Export Council for Northern California.