Study: Comprehensive Antioxidant for Male Patients

Recently, a pilot study was published in the Journal of Cosmetic Dermatology that evaluated the efficacy and tolerability of a comprehensive antioxidant product for male patients.¹

The market for male patients getting cosmetic procedures has been growing in the past decade, according to study authors, with men accounting for 1.1 million minimally invasive cosmetic or plastic surgery procedures in 2019. With this influx of patients and the hormonal and environmental differences between male and female patients, the authors wanted to investigate the efficacy and tolerability of a hydrating topical antioxidant designed specifically for men.

The 12-week single center, open-label, clinical study enrolled male patients, aged 25 to 65 years, who shaved 3 to 4 times per week with mild to moderate photo damaged skin. Participants were instructed to apply comprehensive antioxidant cream, SHD-M, daily. The study was performed by 2 board certified dermatologists under Independent Review Board (IRB; Advarra IRB, Columbia, Maryland) approval with current Good Clinical Practices guidelines.

Patients were excluded if they had unshaven facial hair, had been diagnosed with any dermatologic conditions, or had a history of hypersensitivity to any ingredients in the product. They were also excluded if in the last 2 weeks they had used any cosmetic product with Alpha Hydroxy Acids (AHAs)/Beta Hydroxy Acids (BHAs), peptides, growth factors, antioxidants, and nonprescribed retinoids, unless the patient agreed to a 2-week period of stop of use. Patients who used any oral or topical prescription or over-the-counter acne treatment products, or any prescription retinoid/retinol or like product in the 4 weeks prior to the study had to agree to stop using those products for 4 weeks to be eligible. 

The researchers then examined improvements from baseline in erythema, lines/wrinkles, skin tone, texture, brightness, dryness/flaking, and pores using a 6-point rating scale (0=None, 1=Minimal, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe). Global improvement was also assessed using a 5-point grading scale (0=None, 1=Minimal Improvement, 2=Mild Improvement, 3=Moderate Improvement, 4=Marked Improvement). Sebum levels were obtained by using a noninvasive, bioinstrumentation (Sebumeter SM 815; Courage +Khazaka electronic GmbH, Köln, Germany) from the forehead, cheek, and chin areas at baseline, 4, 8, and 12 weeks. All adverse events (AEs) and subject self-assessments were also counted.

In total, 22 patients completed the trial. Patients had an average age of 40 years with 60% having a Fitzpatrick Skin type (FST) II, 36% were FST III, and 4% FST V. The severity of the photodamaged skin was 52% mild and 48% moderate when starting the study.

The largest improvements from baseline at 4 weeks were:

• 29% skin tone improvement
• 28% pore improvement
• 20% skin tone improvement

At 8 weeks, there was a significant improvement (31%) in skin brightness and at 12 weeks there was mean visible improvements in erythema (24%) and wrinkles (22%). There was a steady improvement in dryness/flaking with an overall improvement of 30% at week 12.

The skin surface sebum measurements were analyzed only at 8- and 12-week timepoints because of fluctuations in readings and the capture of multiple measurements per area at week 4. The protocol was changed to only one reading per region and timepoint. There were significant reductions from baseline at 8 (48%) and 12 (41%) weeks in sebum levels from the forehead. Also, there was a significant reduction in skin surface sebum levels of the left cheek at 8 weeks (43%) and nonsignificant reductions in skin surface sebum levels in the chin region (21% at 8 weeks and 7% at 12 weeks).

Patient satisfaction was steady through 12 weeks with 96% of patients reporting an overall skin appearance improvement at week 4. The patients also reported the product calmed and soothed their skin, reducing redness and irritation after shaving. More so, 96% stated that their skin tone was more even looking and felt smoother at 12 weeks of use and 91% of patients said that their pores were less visible in the same amount of time.

All of the patients reported the treatment was well absorbed and did not leave their skin feeling greasy while having a pleasant texture and feel. There was 1 patient who reported mild skin dryness at week 12 and no other AEs were reported. 

“In conclusion, once-daily use of a comprehensive, hydrating topical antioxidant developed to address the specific needs of male skin demonstrated early, significant visible improvements in the appearance of skin and substantial reductions in skin surface sebum levels over 12 weeks,” the authors wrote. “Subjects reported high levels of satisfaction in their appearance. The study product was well tolerated throughout the study period.”

Reference:

1. Sikora BC, Wortzman M, Nelson DB, Dover JS. A pilot study evaluating the efficacy and tolerability of a comprehensive, hydrating topical antioxidant developed specifically for men. Journal of Cosmetic Dermatology. 2021;20(9):2816-2823. doi:10.1111/jocd.14314