Currently, the standard protocol regarding the performance of procedures on patients receiving or having recently received isotretinoin (13-cis-retinoic acid) states that the procedures should not be performed. The recommendations in standard books and drug insert require discontinuation of isotretinoin for 6 months before performing cosmetic procedures, including waxing, dermabrasion, chemical peels, laser procedures, or incisional and excisional cold-steel surgery. These recommendations have been followed for over two decades despite little evidence for the stated increased risk of scarring.
Objective: The Association of Cutaneous Surgeons (I) constituted a task force to review the evidence and to recommend consensus guidelines regarding the safety of skin procedures, including resurfacing, energy-device treatments, and dermatosurgical procedures in patients with concurrent or recent isotretinoin administration.
Materials and Methods: Data were extracted from the literature through a PubMed search using the keywords “isotretinoin,” “safety,” “scarring,” “keloids,” “hypertrophic scarring,” and “pigmentation.” The evidence was then labeled and circulated to all members of task force for review.
Results: The task force is of the opinion that there is insufficient evidence to support the current protocol of avoiding and delaying treatments in the patient group under consideration and recommends that the current practice should be discontinued.The task force concludes that performing procedures such as laser hair removal, fractional lasers for aging and acne scarring, lasers for pigmented skin lesions, fractional radio-frequency microneedling, superficial and medium-depth peels, microdermabrasion, dermaroller, biopsies, radio-frequency ablation, and superficial excisions is safe in patients with concurrent or recent isotretinoin administration.
Isotretinoin, a retinol derivative of vitamin A widely used in the treatment of acne vulgaris, has many pharmacological actions that affect epidermis, sebaceous gland, and collagen formation. The propensity of isotretinoin to affect these functions has led to questions about the possibility of poor wound healing, keloid development, and hypertrophic scarring, particularly in patients who undergo dermatosurgical procedures while on this drug. A detailed discussion of the mechanisms of action of the drug with respect to wound healing and scar formation has been reported in several standard publications, to which the reader is referred to.
It has been the standard recommendation for over two decades that it is not safe to perform procedures in patients currently receiving or having recently completed systemic therapy with isotretinoin as the drug affects healing of wounds and hence may lead to hypertrophic scarring and keloid formation. Although this has generally been adhered to by practitioners, the recommendation has been questioned by a number of studies that have documented safety of cutaneous procedures in such patients.
The Indian skin is brown and reacts differently to procedures with pigmentation. Hence, it was felt that there is a need for guidelines oriented to the Indian situation. The Association of Cutaneous Surgeons (I), as part of a presidential project by the then President Dr. Venkataram Mysore, conducted a multicentric study to examine the issue in the Indian setting, the findings of which were published recently. A task force was then constituted to formulate and recommend new guidelines appropriate to brown skin.
Materials & Methods
The task force performed a PubMed search using the keywords “isotretinoin,” “isotretinoin side effects,” “isotretinoin,” AND “laser”; “isotretinoin” AND “surgery”; “isotretinoin” AND “keloid”; “isotretinoin” AND “would healing”; “Isotretinoin” AND “hypertrophic scarring, isotretinoin, and pigmentation.” A total of 403, 62, and 27 articles were found with respect to “isotretinoin” AND “surgery”; “Isotretinoin” AND “wound healing”; and “Isotretinoin” AND “laser,” respectively. Of these, 27 articles were found to be of relevance as they specifically referred to the issue of scar formation and keloids. The task force also took into account recent consensus guidelines published by other associations such as the American Society for Dermatologic Surgery and a task force by JAMA (Journal of American Medical Association). The publications were studied in depth with respect to the evidence levels (as per Harbour and Miller’s revised grading system).
All standard textbooks state that performing dermatological procedures is not safe in patients currently or recently administered with isotretinoin and that a safe window period of 6 months after stopping the drug is advisable before performing procedures.
The patient information leaflet of the drug advises patients to “avoid chemical dermabrasion and laser treatment of the skin and wax depilation during and for at least 6 months after treatment as they could cause scarring or irritation of the skin.”
The US Food and Drug Administration (FDA) also advises patients as follows: “Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using Accutane and for at least 6 months after you stop. Accutane can increase your chance of scarring from these procedures. Check with your doctor for advice about when you can have cosmetic procedures.”
Historical basis for the existing guidelines
Some studies, mostly case reports from the 1980s to the 1990s, document delayed healing, hypertrophic scarring, and keloid formation after procedures in patients on oral isotretinoin. The data of these studies, along with their evidence level, are shown in Table 2. During the same period, several other in vitro studies have shown that wound-healing processes can be affected by the administration of retinoids, topically and systemically.
Detailed examination of these studies shows that these are all limited studies in a small number of patients, or isolated case reports of an inadequate number of procedures that were mostly aggressive procedures or conducted with early generation laser devices. The evidence would at best qualify for level 3. Furthermore, these studies were conducted with respect to only certain procedures such as argon laser (which is not no longer used), dermabrasion (which is rarely performed nowadays), and early generation of pulse dye laser (which was far inferior to currently available machines). There were no reports in context to other currently common, noninvasive, or minimally invasive procedures, such as microdermabrasion, microneedling, laser hair removal, fractional laser, and superficial peels.
There was no documentation of ethnicity of patients or any other conflicting factors. It is therefore somewhat perplexing that such limited and basic data in a few procedures could lead to profound and sweeping recommendations applicable to all procedures including noninvasive and minor procedures, and that such recommendations could last for over two decades in clinical practice. It was also made at a time when isotretinoin itself was being subjected to strict evaluation and scrutiny, with respect to various issues such as dosage schedules, side-effect profiles such as psychological effects, teratogenicity, and effects on cholesterol. This was perhaps a knee-jerk and premature reaction and not evidence-based medicine.
Basis for revision of current guidelines
It is interesting and important to note that the existing guidelines did not go unquestioned and reports were published from the very beginning documenting the safety of procedures in this patient group. However, such studies tended to be small, possibly because physicians were deterred from performing large studies due to medicolegal implications. Hence, although these studies were far more in number than the studies that supported the need for a window period in procedures, they did not create sufficient academic impact to alter the recommended guideline. An examination of such studies in each procedure with the available evidence is shown here.