Summary of Evidence

MD Lash Factor® is supported by four converging forms of clinical evidence:

1. An IRB-reviewed in-use ocular safety evaluation (CRL93007) in 35 adult women across 4 weeks, including contact lens wearers and self-assessed sensitive-eye subjects
2. A peer-reviewed clinical study published in the Journal of Cosmetic and Laser Therapy in 2008 (PMID: 18569264)
3. Independent toxicological assessment: Non-Mutagenic (Ames Assay), Non-Cytotoxic (Agarose Overlay), Non-Sensitizing (LLNA) by AppTec Laboratory Services
4. EU Cosmetic Product Safety Report (Regulation (EC) No. 1223/2009) completed by independent assessor Dr. John Hopkins — the assessor's conclusion that the product is safe for its intended use. Regulation (EC) No. 1223/2009 replaced Council Directive 76/768/EEC in July 2013.

MD Lash Factor does not contain bimatoprost or latanoprost. Protected by US Patent 8,206,695.

Study 1: MD Lash Factor® Ocular Safety Evaluation (CRL93007)

Quick summary: MD Lash Factor® was clinically evaluated under an IRB-reviewed, 4-week in-use ocular safety study protocol. The protocol enrolled 35 adult women, including contact lens wearers and individuals with self-assessed sensitive eyes. Subjects applied the product once nightly and completed ophthalmic assessments at baseline and week 4 (slit-lamp examination, fluorescein staining, tear-film break-up time, intraocular pressure). No potential for eliciting ophthalmic irritation was demonstrated under study conditions (n=35, four weeks).

Study at a glance

Ophthalmic examination found no clinically significant change in visual acuity, corneal health, tear film or intraocular pressure over the four-week study.

Study 2: Independent Toxicological Assessment (AppTec Laboratory Services)

MD Lash Factor® has been subjected to standard cosmetic toxicological assays by AppTec Laboratory Services with the following results:

Study 3: EU Cosmetic Product Safety Report (Regulation (EC) No. 1223/2009)

Assessment included

• Toxicological profiles and chemical structures of each ingredient
• Specific exposure characteristics for the intended application area
• Absence of prohibited, restricted, or improperly characterized substances

Study 4: Peer-Reviewed Publication — Journal of Cosmetic and Laser Therapy (2008)

Quick summary: A peer-reviewed clinical study on the eyelash enhancement properties of topical dechloro ethylcloprostenolamide. The study reported a statistically significant increase in lash length after four weeks of nightly use — 42% to 53% across the active groups against 20% for placebo. Length was the measured endpoint; density was not measured.

APA citation

Study 5: Human Repeat Insult Patch Test — Skin Sensitization (CRL 94507)

Quick summary: The MD Lash Factor® formulation was evaluated in a human repeat insult patch test at Clinical Research Laboratories, Inc. Subjects received nine induction applications, then rested for two weeks, and were then challenged at a previously untreated (naive) site — the standard way to separate a simple irritant response from true sensitization. Across 209 subjects, the test article showed no clinically significant potential for dermal irritation or sensitization under the conditions of the study.

Why the panel was this large

209 subjects is an unusually large panel for a cosmetic repeat insult patch test — the conventional standard is 50 to 100. It was run at that scale because of how the product is used: it is applied to the thinnest, most permeable skin on the body, every night, indefinitely. A panel of that size gives a wider view of how a chronically applied product behaves across a general adult population than a conventional panel does.

Study at a glance

Study 6: MD Lash Factor® Ultima Ocular Safety Evaluation (CRL32009)

Quick summary: The prostaglandin-free Ultima formulation was evaluated in its own IRB-reviewed, four-week in-use ocular safety study. Thirty-three female subjects aged 19 to 65 were enrolled, roughly eleven per group across non-contact-lens wearers, contact lens wearers, and subjects with self-assessed sensitive eyes. Thirty-two completed the study; one subject discontinued for reasons unrelated to the test material.

Study at a glance

Findings

• No corneal abnormalities and no superficial punctate keratopathy
• No clinically significant changes in visual acuity or tear film break-up time
• No increases in subjective irritation, lacrimation or eyelid inflammation
• No changes in contact lens colour, scratches or deposits
• No adverse experiences

What subjects recorded in their daily diaries

Four subjects recorded slight-to-moderate transient burning or stinging, lasting from a few seconds to about five minutes. All four completed the study without any change to their schedule and with no increase in measured irritation. Trace (level 1) palpebral conjunctival inflammation was seen in four subjects and trace-to-mild bulbar inflammation in two; the investigator judged these findings unrelated to the test material.

Two points of scope worth stating plainly

Intraocular pressure was not an endpoint of CRL32009. IOP was measured — by Goldmann applanation tonometry — in the flagship study, CRL93007 (Study 1 above), where it is the single most relevant endpoint in the file: the flagship MD Lash Factor® active is a prostaglandin analogue, dechloro ethylcloprostenolamide. Ultima is prostaglandin-free. The two studies cover two different formulations and should not be read together.

This study establishes ocular tolerance only. No efficacy trial has been published on the Ultima formulation, and nothing about lash length, thickness, fullness or density is claimed from CRL32009.

Stability and Microbiological Testing — MD Lash Factor®

Stability and microbiological testing were conducted on MD Lash Factor® as part of the product substantiation package recorded in the AppTec memorandum, reference 200089 (Randy D. White, Ph.D., 1 May 2008).

Preservative efficacy

Microbiological preservative challenge testing was carried out under a double-challenge protocol — the preservative system is challenged with organisms, then challenged again, to confirm it still controls contamination on repeated insult.

Patent: US Patent 8,206,695

Related Clinical Evidence

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  56-day Spincontrol independent consumer-use study (Patrick Beau, Ph.D., Lead Investigator): 78% agreed their brows seemed thicker, 87% agreed their brows seemed healthier, 87% reported no irritation — self-assessment questionnaire responses