A Randomized, Placebo-Controlled Trial of Gamma Linolenic Acid as an Add-on Therapy to Minocycline for the Treatment of Rosacea

Abstract

Background A recent study suggested a possible role of skin barrier dysfunction in the pathogenesis of rosacea, which leads to irritation symptoms. Gamma linolenic acid (GLA) is an essential omega-6 fatty acid that is known to restore defective epidermal skin barrier. GLA supplementation has not previously been performed in rosacea patients. Objective To investigate the efficacy and safety of adding GLA to minocycline compared to minocycline alone in rosacea patients. Methods This prospective, double-blind, randomized, placebo-controlled trial enrolled 31 rosacea patients. They were randomly assigned to receive 320 mg/day of GLA (Evoprim®) (n=16) or placebo (n=15) in addition to 100 mg/day of minocycline for 8 weeks. Investigator's global assessment (IGA) and patient's global assessment (PGA) were used to assess clinical severity at weeks 0, 4, 8, and 12. Biophysical parameters including melanin index, erythema index, transepidermal water loss (TEWL), lipid concentration, and stratum corneum hydration were measured. Results In the GLA group, a higher proportion of patients achieved treatment success (IGA≤1) at week 8 (68.75% vs. 33.33%) and patient satisfaction (PGA≥3) at weeks 8 (75.0% vs. 40.0%) and 12 (81.3% vs. 46.6%). Both groups, throughout 12 weeks of treatment, revealed a trend toward improvement in erythema index, melanin index, TEWL, and stratum corneum hydration. Particularly, there was a significant difference in TEWL and stratum corneum hydration over time between the two groups ( p =0.033, p =0.003, respectively). No serious adverse event was observed in both groups. Conclusion GLA is beneficial as an additional therapeutic option for rosacea patients treated with minocycline.

Use of Patient-Reported Outcomes in Acne Vulgaris and Rosacea Clinical Trials From 2011 to 2021

“…Among 2461 potential studies, 206 satisfied the inclusion criteria (eFigure in the Supplement). Among included trials, 163 (79%) were for acne and 43 (21%) were for rosacea. Rosacea RCTs were more likely to include at least 1 PROM (67% [n = 29 of 43]) compared with acne RCTs…”

“… Among included trials, 163 (79%) were for acne and 43 (21%) were for rosacea. Rosacea RCTs were more likely to include at least 1 PROM (67% [n = 29 of 43]) compared with acne RCTs…”

“…Generic PROMs were included in 82 trials (40%) compared with 27 RCTs (13%) that included a dermatology-specific PROM and 28 (14%) that included a disease-specific PROM . The most used PROMs were patient global assessments and patient satisfaction questionnaires (Table 2).…”

Psychological Burden and Willingness to Pay Among Korean Rosacea Patients and Their Association With Rosacea Phenotype and Severity: A Multi-Center Cross-Sectional Study

“…The IGA score used a 5-point scale that included 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). 16,17 The severity of flushing was assessed by the patient utilizing the GFSS on a scale of 0 to 10. 17 GFSS questions the overall degree of flushing symptoms during the past 24 hr, including redness, warmth, tingling, or itching of the patient’s skin.…”

Emulgels Containing Perilla frutescens Seed Oil, Moringa oleifera Seed Oil, and Mixed Seed Oil: Microemulsion and Safety Assessment

“…Gamma-linolenic acid has antioxidant activity that can be used to protect skin from environmental damage and skin aging [4,5]. The double blinded placebo controlled clinical study investigated by Kim et al has shown that gamma-linolenic acid can improve erythema index, melanin index, Transepidermal water loss, and stratum corneum hydration in most volunteers without serious side effects [6]. Alpha-linolenic acid and linoleic acid were shown to accelerate the turnover of the stratum corneum and played an important role in the melanin pigment removal from the epidermis.…”