A split-face clinical trial to compare efficacy of topical tretinoin 0.025% with and without intense pulsed light 530 nm filter in young adult patients of grades 2 and 3 facial acne vulgaris with Fitzpatrick phototype IV-VI

INTRODUCTION

Acne vulgaris is a common skin condition, prevalent among adolescents. Although it is not life-threatening, it can have a significant impact on an individual’s mental and emotional well-being, often leading to decreased self-confidence. The exact cause of acne vulgaris remains unknown, but its development is attributed to various factors including hormonal, microbiological, and immunological mechanisms.¹ The current treatments range from topical and systemic agents to laser and photodynamic therapies, with the choice of therapy depending on factors such as the patient’s age, the site, and the severity of acne. Topical tretinoin is a commonly used and effective treatment for acne due to its ability to promote skin cell turnover and sebostatic effect.² In recent years, intense pulsed light (IPL) therapy has emerged as a promising treatment modality and is proven to reduce Propionibacterium acnes proliferation and sebum production.³ Our study aims to investigate the efficacy of combining topical tretinoin 0.025% cream with IPL 530 nm filter to achieve improved outcomes for individuals with acne vulgaris.

MATERIAL AND METHODS

The study was a split-face controlled clinical trial conducted on young adult patients >18 years of age with grades 2 and 3 acne vulgaris with Fitzpatrick Grade IV-VI at the Department of Dermatology and Venereology at a tertiary care hospital. The ethics approval and study registration number was ECARP/2022/180.

It was conducted over 18 months and the study involved using the split-face method to compare the efficacy of a combination of topical tretinoin 0.025% with IPL 530 nm filter on one side of the face with only topical tretinoin 0.025% on the other half of the face. The study was conducted for 18 months and convenience sampling was used to select patients willing to undergo the study. The calculated sample size was 32. A randomization sequence was created, and allocation concealment was achieved using sequentially numbered sealed opaque envelopes. The inclusion criteria comprised patients aged above or equal to 18 years with grade 2–3 facial acne vulgaris, while exclusion criteria included a history of photosensitivity, pregnancy, and inability to follow-up for IPL sessions. The study instruments included the modified global acne grading scale (GAGS) score and absolute lesion counts (ALCs) for inflammatory papules and pustules on both sides of the face, and these measurements were taken at baseline, 1 month, 2 months, and 3 months after treatment. Percentage differences in modified GAGS and ALC were calculated at 1, 2, and 3 months after treatment for both sides of the face. Mean, standard deviation, and median were computed for each parameter at the specified time points.

The intervention involved the treatment of the entire face with tretinoin 0.025% cream applied once a day at night. A test patch was conducted on the left post-auricular area, and if no adverse effects were observed, the patient underwent three sessions of IPL at 4-week intervals. On the day of IPL session, skin was prepared with normal saline, povidone iodine, and chilled ultrasonography gel. Both the patient and investigator wore protective eyewear during the procedure. The initial fluence was adjusted based on phototype, single-pulse mode IPL was used, and the skin was treated using horizontal and vertical stamps with a cooling system. The patient underwent three sessions of IPL at 4-week intervals. They were observed for adverse events, and patients already using sunscreens before the study were asked to continue the same. Furthermore, all the participants were asked to use strict physical photoprotection methods between sessions.

RESULTS

The age distribution of the participants with grade 2 and 3 acne vulgaris ranged from 19 to 27 years, with a mean age of 22.66 ± 2. Among them, 53.13% were aged between 22 and 24 years, 31.25% were aged 19–21 years, and 15.63% were aged 25–27 years. 71.88% of the study participants were female, showing a female predominance and all had regular menstrual history. Significant difference was seen in the GAGS score, ALC of papules and pustules of patients with grade 2 and 3 acne vulgaris between baseline and after 1 month, 2 months, and 3 months in both tretinoin and tretinoin plus IPL groups (P < 0.05). In addition, the combination therapy group exhibited a higher percentage reduction in GAGS scores and ALCs throughout the 3-month period [Tables 1-3 and Figures 1-8].

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Figure 1:

Baseline photograph of side with topical tretinoin 0.025% treatment alone.

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Figure 2:

Photograph after 1^st month of treatment of side with topical tretinoin 0.025% treatment alone.

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Figure 3:

Photograph after 2^nd month of treatment of side with topical tretinoin 0.025% treatment alone.

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Figure 4:

Photograph after 3^rd month of treatment of side with topical tretinoin 0.025% treatment alone.

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Figure 5:

Baseline photograph of side with topical tretinoin 0.025% plus intense pulsed light 530 nm treatment.

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Figure 6:

Photograph after 1^st month of treatment of side with topical tretinoin 0.025% plus intense pulsed light 530 nm treatment.

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Figure 7:

Photograph after 2^nd month of treatment of side with topical tretinoin 0.025% plus intense pulsed light 530 nm treatment.

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Figure 8:

Photograph after 3^rd month of treatment of side with topical tretinoin 0.025% plus intense pulsed light 530 nm treatment.

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DISCUSSION

Effectively treating acne vulgaris is of utmost importance due to its potential to cause significant psychological distress, as well as the risk of long-term scarring and pigmentation that can affect a person’s confidence and quality of life.

The incidence of acne vulgaris in our study showed that males were more affected in the 19–21-year age group, whereas females were more affected in the 22–24-year group. These findings differ from a study by Karan et al., which reported a higher prevalence in males across most age groups.⁴

Our study compared tretinoin 0.025% cream alone and tretinoin combined with IPL therapy in the treatment of grades 2 and 3 acne vulgaris. The baseline GAGS score showed no significant difference between the groups. However, after 1, 2, and 3 months, the GAGS scores significantly decreased in both groups, with the combination therapy group showing a more substantial reduction (P < 0.05). This finding aligns with the results of Karan et al., who demonstrated the added efficacy of IPL as an adjuvant therapy with topical adapalene in reducing both inflammatory and non-inflammatory acne lesions.⁴

Further analysis revealed that both treatment groups experienced a significant decrease in the ALC of inflammatory papules over time. However, the reduction was more pronounced in the tretinoin plus IPL group compared to the tretinoin monotherapy group, especially after 2 and 3 months (P < 0.05). For pustules, similar trends were observed, with the combination therapy showing superior efficacy.

Our study’s results on the combination of IPL with tretinoin are consistent with findings from other studies. For example, Kim et al. compared photopneumatic therapy and IPL for acne treatment and found that both methods significantly reduced lesion counts, with photopneumatic therapy being more effective than IPL alone.⁵ Similarly, Kumaresan and Srinivas demonstrated that IPL monotherapy with burst-pulse mode was more effective than single-pulse mode, emphasizing the potential for optimizing IPL treatment parameters to enhance acne clearance.⁶

In our study, transient erythema and burning sensations were observed in some patients after IPL sessions, but these side effects resolved within 1–2 days [Figures 9 and 10]. This is in line with other studies, such as those by Karan et al. and Percy were similar side effects were reported but were generally mild and temporary.^4,7

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Figure 9:

Photograph of side of the face before intense pulsed light treatment.

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Figure 10:

Mild erythema seen post-intense pulsed light treatment.

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In terms of patient satisfaction, Mokhtari et al. found that patients undergoing IPL combined with benzoyl peroxide (BP) were more satisfied than those receiving BP alone, further supporting the benefits of combining IPL with topical therapies for acne treatment.⁸ In other studies, Mokhtari et al. found no significant difference in efficacy between IPL combined with adapalene and IPL combined with BP. Using BP can reduce the cost of treatment considerably.⁹

These findings suggest that IPL, when used with topical agents such as tretinoin, adapalene, or BP, provides additional benefits by reducing lesion counts more effectively and quickly.

CONCLUSION

Tretinoin 0.025% cream is an effective treatment for both inflammatory and non-inflammatory acne lesions, with minimal side effects. When combined with IPL therapy, tretinoin shows enhanced efficacy, leading to faster lesion clearance and reduced acne sequelae such as pigmentation. IPL therapy 530 nm filter is well-tolerated with transient side effects. Based on our findings, we recommend using combination therapy with tretinoin and monthly IPL sessions, and patients may need more sittings for better treatment outcomes. If we use this combination of tretinoin and IPL, we can treat mild-to-moderate acne thus reducing the use of systemic antibiotics and isotretinoin and avoiding side effects of these drugs. A larger, more diverse cohort with extended follow-up would strengthen the study’s conclusions. Further studies are needed to compare its efficacy with other combination therapies for comprehensive acne management.