A Randomized Controlled Prospective Cohort Study on the Efficacy of a Witch Hazel Extract Cream for the Eyelids and Eye Contour Area and a Cleansing Face Cream in Dermatitis of the Eyelids
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
Inclusion and Exclusion Criteria
- Aged over 18 years.
- Signature of informed consent.
- Patients able to understand and respond to the questionnaires required by the study.
- Patients able to understand the application method of the cream (independently at their home) and who can guarantee the regularity of the checks.
- Absence of consent to participate.
- Absence of clinical signs compatible with eyelid dermatitis.
- Inability to understand the questionnaires and impossibility of autonomous application of the product.
- Failure to guarantee regularity in follow-up visits.
- Concomitant treatment with topical or systemic corticosteroids or other immunosuppressive drugs.
2.2. Treatment
Treatment Group | Placebo Group | |
Cream | Cleanser | Cream |
Aqua (Water) • Caprylic/capric Triglyceride • Glycerin • Pentylene glycol • Trehalose • Hydroxyethyl Cellulose • Plukenetia Volubilis Seed Oil • Methylpropanediol • Arachidyl alcohol • Hamamelis Virginiana (Witch Hazel) Bark/Twig Extract • Behenyl Alcohol • Arachidyl Glucoside. | Aqua (Water) • Glycerin • Pentaerythrityl Tetraethylhexanoate • Pentylene Glycol • Methyl Glucose Sesquistearate • Hydroxyethylcellulose •Xanthan Gum • Tetrasodium Glutamate Diacetate • Methylpropanediol • Lactic Acid • Hamamelis Virginiana (Witch Hazel) Bark/Twig Extract • Sodium Hydroxide. | Aqua (Water), Caprylic/Capric Triglyceride, Glycerin, Pentylene Glycol, Hydroxyethylcellulose, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside |
2.3. Dermatological Variables
- -
- OSDI (Ocular surface disease index): evaluates the dry eye disease severity and effect on vision-related function, its scores vary from 0 to 100 (the higher scores representing greater disability) [17].
- -
- NRS–itch (Numerical rating scale for pruritus): measures the intensity of itch using a scale from 0 (no itch) to 10 (worst imaginable itch) [18].
- -
- EDSI (Eyelid dermatitis severity index): evaluates eyelid dermatitis in terms of erythema, papules, and scaling. It ranges from 0 to 9 (modified by [19]).
- -
- DLQI (Dermatology life quality index): estimates patients’ perception of the impact of skin diseases in different aspects of their health-related quality of life in the last week. Score assumed values between 0 (no effect at all on patient’s life) and 30 (extremely large effect on patient’s life) [20].
2.4. Primary Outcome
2.5. Sample Size
2.6. Statistical Analysis
3. Results
3.1. Patients
3.2. Clinical Characteristics at Baseline
3.3. Response to Treatment
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Variable | Level | Overall (n = 30) | Control (n = 14) | Treatment (n = 16) |
---|---|---|---|---|
Gender | Male | 10 (33.33) | 5 (35.71) | 5 (31.25) |
Female | 20 (66.67) | 9 (64.29) | 11 (68.75) | |
Age, years | ||||
Median [Q1–Q3] | 45.87 [31.77; 60.98] | 47.97 [23.10; 60.98] | 44.23 [34.71; 59.14] | |
Exposure at work | Yes | 5 (16.67) | 2 (14.29) | 3 (18.75) |
Diagnosis | Atopic dermatitis | 21 (72.41) | 12 (85.71) | 9 (60) |
DIC/DAC | 8 (27.59) | 2 (14.29) | 6 (40) | |
Comorbidities | Allergic asthma | 7 (23.33) | 4 (28.57) | 3 (18.75) |
Allergic rhinitis | 10 (33.33) | 8 (57.14) | 2 (12.5) | |
Allergic conjunctivitis | 4 (13.33) | 2 (14.29) | 2 (12.5) | |
Known allergies | 14 (46.67) | 8 (57.14) | 6 (37.5) | |
Dermatitis onset | <6 months | 7 (23.33) | 2 (14.29) | 5 (31.25) |
6+ months | 23 (76.67) | 12 (85.71) | 11 (68.75) | |
Previous lesions | Yes | 22 (78.57) | 12 (92.31) | 10 (66.67) |
Topics use | Yes | 26 (89.66) | 12 (92.31) | 14 (87.5) |
Face wash per day | 0–1 | 6 (20) | 2 (14.29) | 4 (25) |
2+ | 24 (80) | 12 (85.71) | 12 (75) | |
Previous dermatologic visit | Yes | 25 (83.33) | 12 (85.71) | 13 (81.25) |
Variable | Level | Overall (n = 30) | Control (n = 14) | Treatment (n = 16) |
---|---|---|---|---|
Edema | Yes | 12 (40) | 5 (35.71) | 7 (43.75) |
Vesiculation | Yes | 5 (16.67) | 1 (7.14) | 4 (25) |
Dermatitis type | Unilateral | 7 (23.33) | 2 (14.29) | 5 (31.25) |
Bilateral | 23 (76.67) | 12 (85.71) | 11 (68.75) | |
Position | Over palpebral | 5 (16.67) | 1 (7.14) | 4 (25) |
Under and over palpebral | 25 (83.33) | 13 (92.86) | 12 (75) | |
Extension | 1–25% | 4 (13.33) | 1 (7.14) | 3 (18.75) |
26–50% | 6 (20) | 2 (14.29) | 4 (25) | |
51–75% | 9 (30) | 6 (42.86) | 3 (18.75) | |
76–100% | 11 (36.67) | 5 (35.71) | 6 (37.5) | |
DLQI | ||||
Median [Q1–Q3] | 4.00 [1.00; 10.00] | 5.50 [1.00; 10.00] | 3.00 [1.00; 8.50] | |
OSDI | ||||
Median [Q1–Q3] | 22.92 [6.25; 35.42] | 19.79 [6.25; 29.17] | 22.92 [9.38; 37.50] | |
NRS–itch | ||||
Median [Q1–Q3] | 7.00 [5.00; 8.00] | 6.00 [3.00; 8.00] | 7.00 [5.00; 8.00] | |
EDSI erythema | ||||
Median [Q1–Q3] | 2.00 [1.50; 3.00] | 2.00 [1.50; 3.00] | 2.25 [1.25; 3.00] | |
EDSI papules | ||||
Median [Q1–Q3] | 0.50 [0.50; 1.50] | 0.50 [0.00; 1.00] | 0.50 [0.50; 2.25] | |
EDSI scaling | ||||
Median [Q1–Q3] | 1.50 [0.50; 2.00] | 1.50 [0.50; 2.00] | 1.50 [0.50; 2.25] | |
EDSI total | ||||
Median [Q1–Q3] | 4.00 [3.50; 7.50] | 3.75 [3.50; 5.50] | 4.00 [3.00; 7.50] |
Variable | Overall (n = 30) | Control (n = 14) | Treatment (n = 16) | p-Value |
---|---|---|---|---|
Improvement T1 vs. T0 | ||||
Edema | 2 (6.67) | 1 (7.14) | 1 (6.25) | >0.999 |
Vesiculation | 3 (10.34) | 0 (0.00) | 3 (18.75) | 0.23153 |
Dermatitis type | 0 | 0 | 0 | |
Position | 2 (6.9) | 1 (7.69) | 1 (6.25) | >0.999 |
Extension | 13 (43.33) | 6 (42.86) | 7 (43.75) | >0.999 |
Improvement T2 vs. T0 | ||||
Edema | 4 (13.79) | 2 (15.38) | 2 (12.5) | >0.999 |
Vesiculation | 3 (10.34) | 0 | 3 (18.75) | >0.999 |
Dermatitis type | 0 | 0 | 0 | |
Position | 5 (17.24) | 2 (15.38) | 3 (18.75) | >0.999 |
Extension | 15 (53.57) | 7 (58.33) | 8 (50) | 0.71768 |
Variable | Overall | Control | Treatment | p-Value |
---|---|---|---|---|
Difference T1 vs. T0 | ||||
DLQI | −0.63 (3.77) | −0.14 (3.63) | −1.06 (3.96) | 0.5150 |
OSDI | −3.89 (11.08) | −1.24 (10.2) | −6.20 (11.61) | 0.2275 |
NRS | −0.97 (2.47) | −0.64 (1.91) | −1.27 (2.94) | 0.5069 |
EDSI total | −0.9 (2.39) | −0.75 (2.73) | −1.03 (2.14) | 0.7543 |
Difference T2 vs. T0 | ||||
DLQI | −2.24 (4.52) | −1.62 (3.2) | −2.75 (5.42) | 0.5118 |
OSDI | −3.81 (8.99) | −2.94 (6.83) | −4.51 (10.6) | 0.6489 |
NRS | −1.96 (2.93) | −1.54 (3.1) | −2.38 (2.81) | 0.4732 |
EDSI total | −1.52 (2.66) | −1.15 (2.98) | −1.81 (2.43) | 0.5173 |
Beta [95% CI] | p-Value | |
---|---|---|
DLQI | ||
T1 vs. T0 | 0.63 [−1.96; 0.69] | 0.3498 |
T2 vs. T0 | −2.01 [−3.66; 0.37] | 0.0165 |
Treatment vs. control | −1.42 [−4.55; 1.70] | 0.3725 |
OSDI | ||
T1 vs. T0 | −3.99 [−7.79; 0.01] | 0.0505 |
T2 vs. T0 | −3.25 [−6.56; 0.07] | 0.0551 |
Treatment vs. control | 1.34 [−11.22; 13.90] | 0.8341 |
NRS | ||
T1 vs. T0 | −0.96 [−1.83; −0.09] | 0.0301 |
T2 vs. T0 | −1.63 [2.77; −0.49] | 0.0049 |
Treatment vs. control | −0.19 [−1.90; 1.52] | 0.8245 |
EDSI | ||
T1 vs. T0 | −0.90 [1.74; −0.06] | 0.0361 |
T2 vs. T0 | −1.44 [2.39; −0.49] | 0.0030 |
Treatment vs. control | 0.01 [−1.21; 1.23] | 0.9859 |
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Veronese, F.; Esposto, E.; Airoldi, C.; Di Cristo, N.; Paganini, P.; Savoia, P.; Zavattaro, E. A Randomized Controlled Prospective Cohort Study on the Efficacy of a Witch Hazel Extract Cream for the Eyelids and Eye Contour Area and a Cleansing Face Cream in Dermatitis of the Eyelids. Cosmetics 2024, 11, 83. https://doi.org/10.3390/cosmetics11030083
Veronese F, Esposto E, Airoldi C, Di Cristo N, Paganini P, Savoia P, Zavattaro E. A Randomized Controlled Prospective Cohort Study on the Efficacy of a Witch Hazel Extract Cream for the Eyelids and Eye Contour Area and a Cleansing Face Cream in Dermatitis of the Eyelids. Cosmetics. 2024; 11(3):83. https://doi.org/10.3390/cosmetics11030083
Chicago/Turabian StyleVeronese, Federica, Elia Esposto, Chiara Airoldi, Nunzia Di Cristo, Pamela Paganini, Paola Savoia, and Elisa Zavattaro. 2024. "A Randomized Controlled Prospective Cohort Study on the Efficacy of a Witch Hazel Extract Cream for the Eyelids and Eye Contour Area and a Cleansing Face Cream in Dermatitis of the Eyelids" Cosmetics 11, no. 3: 83. https://doi.org/10.3390/cosmetics11030083
APA StyleVeronese, F., Esposto, E., Airoldi, C., Di Cristo, N., Paganini, P., Savoia, P., & Zavattaro, E. (2024). A Randomized Controlled Prospective Cohort Study on the Efficacy of a Witch Hazel Extract Cream for the Eyelids and Eye Contour Area and a Cleansing Face Cream in Dermatitis of the Eyelids. Cosmetics, 11(3), 83. https://doi.org/10.3390/cosmetics11030083