It is often difficult to achieve an objective definition of beauty. It is even more difficult to assess the self-perception of beauty at a cognitive level. Though FDA often does not get involved much in the realm of cosmetic dermatology, Botox(R) is indeed a different matter as it is an injectable with real medical indications. Do upper facial lines (UFL) cause enough psychological morbidity to justify intervention? FDA might ask for real evidence and we better be ready.
To prove the impact of UFL treatment, first of all we need a validated tool. FDA recommends patient-reported outcome instruments or PRO as objective evidence. PRO as defined by FDA
is any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.
One of the PRO instruments available for upper facial lines is the FLO-11 questionnaire. But unfortunately FLO-11 is not validated to the FDA standards. You don’t usually find many good qualitative studies in cosmetic dermatology. But this study 1 stands apart and has been quite methodical in validating the FLO-11 questionnaire.
Yet another study in the same journal 2 presents another questionnaire called Aesthetic Dermatology and Emotional Well-being (DEBIE), designed to know the general population motivations with regard to skin appearance. Though DEBIE is quite long, the authors have done a good job in validating the questionnaire using qualitative research principles. An abridged version may be more practical.
Both these questionnaires will be useful for those planning patient satisfaction studies in cosmetic dermatology. All we need now is proof. Botulinum Toxin for UFL is fortunately our best shot at objective proof.
As a side note, a recent study 3 reported the rarely noticed phenomenon of primary resistance to BoNT-A. The authors propose the following factors as probable explanation for primary resistance:
- Genetically induced resistance
- Insufficient dosing
- Handling errors during drug storage and reconstitution
- and improper muscle injection site.
Human factors are likely to be more common. A genetic variation in muscle anatomy may also contribute to this.
Secondary resistance (resistance after multiple treatments) is commonly reported, though I suggested many years back that neutralizing antibodies might not be a major concern because of the molecular peculiarities of BoNT-A. (I did not have any clinical proof.) 4
How often do you encounter resistance to Botulinum Toxin in your practice?
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- Yaworsky A, Daniels S, Tully S, Beddingfield F 3rd, Kowalski J, Fitzgerald K, Somogyi C, Burgess SM. The impact of upper facial lines and psychological impact of crow’s feet lines: content validation of the Facial Line Outcomes (FLO-11)
Questionnaire. J Cosmet Dermatol. 2014 Dec;13(4):297-306. doi: 10.1111/jocd.12117. PubMed PMID: 25399622. ↩
- Martínez-González MC, Martínez-González RA, Guerra-Tapia A. Aesthetic dermatology and emotional well-being questionnaire. J Cosmet Dermatol. 2014
Dec;13(4):336-45. doi: 10.1111/jocd.12109. PubMed PMID: 25399627. ↩
- Stephan, F., Habre, M. and Tomb, R. (2014), Clinical resistance to three types of botulinum toxin type A in aesthetic medicine. J Cosmet Dermatol, 13: 346–348. doi:10.1111/jocd.12108 ↩
- Eapen BR. Molecular biology of botulinum neurotoxin serotype A: a cosmetic perspective. J Cosmet Dermatol. 2008 Sep;7(3):221-5. doi: 10.1111/j.1473-2165.2008.00392.x. PubMed PMID: 18789058. ↩