the lack of reliable validated outcome measures in dermatology. 16 They have been shown to provide superior interobserver agreement when compared with purely descriptive scales,17,18 and they have demonstrated consistency, precision, and reproducibility. 16 A photonumeric scale assigns numbers to images that represent diversity of appearance to facilitate a rating or grading process, usually from good to poor. Current validated photonumeric scales are based on lip shape and contour and are designed to standardize evaluations, quantify results, and measure the longevity of dermal fillers and other procedures for lip rejuvenation in clinical trials.16 Additionally, these scales are used to evaluate the effectiveness of lip augmentation in clinical trials of hyaluronic acid gel (a type of dermal filler) injection19 and to objectively quantify lip volume in clinical practice relative to aesthetic procedures.20 These scales focus on technologies and applications that are designed to enhance and beautify the lips; therefore, they do not directly assess lip health. Dermal fillers are cosmetic tools for “anti-aging” and “rejuvenation”21 that have the same goals as lip peels,22 implants,23 lifts,24 and related procedures. Current scales are associated with cosmetic terms such as “augmentation” and “renewal.”12,20 Therefore, this article describes the methodology that was used to develop a photonumeric lip health assessment scale for clinical use and evaluating the efficacy of lip care products in improving lip health.
METHODS
Study Design, Setting, and Subjects
This was a single-site study conducted at Dermatology Consulting Services, High Point, North Carolina, that utilized a research team comprising the primary dermatologist investigator (ZDD) and 2 external dermatologists who also formed the panel that reviewed the photographs and used the proposed ordinal rating scale to assess lip health. The study protocol was submitted to a sponsor-approved Institutional Review Board (Allendale Institutional Review Board, Lyme, Connecticut). To protect confidentiality, subject data were identified by number and subject initials only. The principles of Informed Consent according to US Food and Drug Administration regulations and the International Council for Harmonisation Guideline for Good Clinical Practice were followed. One hundred subjects were planned to be enrolled to obtain 100 evaluable lip images. An additional 3 subjects were enrolled to obtain images for correcting any deficiencies in the dataset. This sample size was based on the primary investigator’s previous experience with developing photonumeric scales.
Prescreening involved selection of candidates from the research center database. These candidates were contacted and asked to provide a current photograph of their lips for the research site to determine if they were suitable for study imaging. Those found to be initially suitable and those who did not provide a photograph were invited to the research site for in-person qualification via a dermatologic lip examination performed by the primary investigator. Screening involved the primary investigator assessing potential subjects according to the inclusion and exclusion criteria (Table 1). No specific lip conditions or diseases were excluded from the study. The goal of screening was to include a wide variety of lip conditions within Fitzpatrick skin types I–III. Other Fitzpatrick skin types were excluded because the lip architecture is different among individuals with higher Fitzpatrick ratings.25
Subjects were selected to participate based on whether their lip features met any of the predetermined ordinal ratings for health on the 3 key lip characteristics: shine, texture, and vermilion border. After being fully informed of the study objectives and procedures, eligible subjects signed an informed consent form that included photography consent. At the conclusion of photography, subject participation in the study was complete.
Concomitant Medications
Subjects were allowed to continue all oral and topical medications, which remained unchanged during the study, and no medications were prohibited. However, subjects were required to discontinue use of all lip cosmetics, lip balms, lipsticks, and lip gloss 24 hours prior to study enrollment and were restricted from using any of these products until their study participation was complete. In addition, no skincare products or topical medications of any kind were used on the face or lips on the day of photography. Subjects were advised to present to the research facility with nothing on their lips.
Procedure
All enrolled subjects underwent VISIA®-CR 4.3 photography of
This was a single-site study conducted at Dermatology Consulting Services, High Point, North Carolina, that utilized a research team comprising the primary dermatologist investigator (ZDD) and 2 external dermatologists who also formed the panel that reviewed the photographs and used the proposed ordinal rating scale to assess lip health. The study protocol was submitted to a sponsor-approved Institutional Review Board (Allendale Institutional Review Board, Lyme, Connecticut). To protect confidentiality, subject data were identified by number and subject initials only. The principles of Informed Consent according to US Food and Drug Administration regulations and the International Council for Harmonisation Guideline for Good Clinical Practice were followed. One hundred subjects were planned to be enrolled to obtain 100 evaluable lip images. An additional 3 subjects were enrolled to obtain images for correcting any deficiencies in the dataset. This sample size was based on the primary investigator’s previous experience with developing photonumeric scales.
Prescreening involved selection of candidates from the research center database. These candidates were contacted and asked to provide a current photograph of their lips for the research site to determine if they were suitable for study imaging. Those found to be initially suitable and those who did not provide a photograph were invited to the research site for in-person qualification via a dermatologic lip examination performed by the primary investigator. Screening involved the primary investigator assessing potential subjects according to the inclusion and exclusion criteria (Table 1). No specific lip conditions or diseases were excluded from the study. The goal of screening was to include a wide variety of lip conditions within Fitzpatrick skin types I–III. Other Fitzpatrick skin types were excluded because the lip architecture is different among individuals with higher Fitzpatrick ratings.25
Subjects were selected to participate based on whether their lip features met any of the predetermined ordinal ratings for health on the 3 key lip characteristics: shine, texture, and vermilion border. After being fully informed of the study objectives and procedures, eligible subjects signed an informed consent form that included photography consent. At the conclusion of photography, subject participation in the study was complete.
Concomitant Medications
Subjects were allowed to continue all oral and topical medications, which remained unchanged during the study, and no medications were prohibited. However, subjects were required to discontinue use of all lip cosmetics, lip balms, lipsticks, and lip gloss 24 hours prior to study enrollment and were restricted from using any of these products until their study participation was complete. In addition, no skincare products or topical medications of any kind were used on the face or lips on the day of photography. Subjects were advised to present to the research facility with nothing on their lips.
Procedure
All enrolled subjects underwent VISIA®-CR 4.3 photography of
