Effectiveness and Tolerability of Excela Moisturizer in Patients Prescribed with Isotretinoin for Acne
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6 Jun, 23

Introduction 

Oral isotretinoin (13-cis isomer of retinoic acid) is the prescribed retinoid for treating acne. However, it is associated with severe dryness of skin, especially during the first month of treatment.

Excela (Cipla Ltd., Mumbai, India) is a dermocosmetic moisturiser developed for oily and acne-prone skinIt recreates the skin’s own natural moisture, reduces sebum secretion, and possesses anti-inflammatory effects.

  

Aim 

To evaluate efficacy and safety of Excela moisturiser in patients with acne who were prescribed isotretinoin in daily clinical practice.

  

Patient Profile

Adult patients (aged 18 years) who had been prescribed isotretinoin and Excela moisturizer (as an adjuvant therapy) for managing their acne

  

Methods

  • Open-label, observational, prospective, non-comparative multicentre study

  • N=200

  • Patients were prescribed Excela moisturiser as an adjuvant to isotretinoin for acne

  •  All patients were advised to apply moisturiser (1gm) twice daily for four weeks, and they were followed-up clinically post treatment at week 4 (±2 days)

  •   

Study Endpoint

  • The investigator graded the patient’s skin on smoothness and softness on a five-point scale and dryness, scaling and redness on a four-point scale after 4 weeks 

  • Its organoleptic characteristics and tolerability were evaluated using the subject assessment questionnaire.

  •   

Results 

Effectiveness

  • Investigators rated smoothness and softness of the skin as very good to excellent in 64.5% and 56.5% patients, respectively.

  • None of the patients had severe dryness, scaling or redness of skin after 4 weeks of treatment.

 

Table 1: Effectiveness of the moisturiser using investigator assessment questionnaire (n=200)

 
 
 
 
 
 
 

Grade de

 
 
 
 

Investigator assessment N (%)

 
 

Smoothness

 
 

Softness

 
 

 

 
 
 
 

Excellent

 
 

22 (11)

 
 

17 (8.5)

 
 

 

 
 
 
 

Very good

 
 

107 (53.5)

 
 

96 (48.0)

 
 

 

 
 
 
 

Good

 
 

67 (33.5)

 
 

83 (41.5)

 
 

 

 
 
 
 

Fair

 
 

2 (1.0)

 
 

4 (2.0)

 
 

 

 
 
 
 

None

 
 

2 (1.0)

 
 

-

 
 

 

 
 
 
 

Grade

 
 

Dryness

 
 

Scaling

 
 

Redness

 
 
 
 

None

 
 

59 (29.5)

 
 

112 (56.0)

 
 

141 (70.5)

 
 
 
 

Mild

 
 

93 (46.5)

 
 

65(32.5)

 
 

49 (24.5)

 
 
 
 

Moderate

 
 

48 (24.0)

 
 

23 (11.5)

 
 

10 (5.0)

 
 
 
 

Severe

 
 

-

 
 

-

 
 

 

 

Table 2: Overall clinical impression of the product in patients after four weeks of treatment (n=200) 

 
 
 
 
 
 
 

Overall clinical impression

 
 
 
 

N (%)

 
 
 
 

Excellent/Good

 
 

90 (45)

 
 
 
 

Consistent use of moisturiser (Excela) is recommended

 
 

2(10.5)

 
 
 
 

Dryness reduced

 
 

9 (4.5)

 
 
 
 

Satisfactory

 
 

9 (4.5)

 
 
 
 

Excellent product to take care of

retinoid-induced dryness

 
 

6 (3.0)

 
 
 
 

Reduces scaling

 
 

6 (3.0)

 
 
 
 

Reduces skin redness

 
 

5 (2.5)

 
 
 
 

Smoothness

 
 

3 (1.5)

 
 
 
 

Soft

 
 

3 (1.5)

 
 
 
 

Irritation reduced

 
 

2 (1.0)

 
 
 
 

Well accepted and appreciated by the

Patient

 
 

2 (1.0)

 
 
 
 

After application of moisturiser(Excela), skin looks soft

 
 

1 (0.5)

 
 
 
 

Non-greasy

 
 

1 (0.5)

 
 
 
 

Spreadability

 
 

1 (0.5)

 
 
 
 

Non-sticky

 
 

1 (0.5)

 
 
 
 

Skin is hydrated

 
 

1 (0.5)

 
 
 
 

Very good to apply

 
 

1 (0.5)

 
 
 
 

Patient feels better as far as lesion and suppleness of skin is concerned

 
 

1(0.5)

 

Organoleptic Characteristics and Tolerability 

  • Most noteworthy was the acceptable rating from end-users regarding characteristics of the moisturiser

  • Very good to excellent spreadability, appeal and satisfaction was rated by 66.0%, 66.5% and 91% patients, respectively. 

  • 40% patients rated the moisturizer as non-greasy/non-sticky

  

Table 3: Organoleptic characteristics and tolerability of the moisturiser using the subject assessment questionnaire 

 
 
 
 
 
 
 

Grade

 
 
 
 

Organoleptic and tolerability of Moisturizer, N (%)

 
 

Spreadability

 
 

Appealing

 
 

Overall satisfaction

 
 
 
 

Excellent

 
 

37 (18.5)

 
 

36

(18)

 
 

70 (35)

 
 
 
 

Very

Good

 
 

95 (47.5)

 
 

97

(48.5)

 
 

112 (56)

 
 
 
 

Good

 
 

52 (26)

 
 

57

(28.5)

 
 

17 (8.5)

 
 
 
 

Fair

 
 

14 (7)

 
 

10

(5)

 
 

1 (0.5)

 
 
 
 

None

 
 

2 (1)

 
 

-

 
 

-

 

 

  • No incidence of serious AE or moisturiser-related AE were reported. 

  • Itching (1%), redness (0.5%), cold (0.5%), and cough (0.5%) were reported as adverse events but were of mild intensity and unrelated to the study product.

 

Conclusion

  • In real-world settings, Excela moisturizer demonstrated efficacy and safety in acne patients treated with isotretinoin 

  • Cutaneous side-effects such as dryness, erythema and scaling were reduced with the use of Excela moisturizer 

  • It can be considered as an effective option among dermocosmetic moisturisers and can be used as an adjunct to pharmacotherapy for management of acne

 

Reference

Int J Res Dermatol. 2023 Mar;9(2):67-72