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Clinical benefit and tolerance profile of a keratolytic and hydrating shampoo in subjects with mild to moderate psoriasis. Results from a double-blind, randomized, vehicle-controlled study.
J Cosmet Dermatol. 2023 Mar 21 [Online ahead of print]JC

Abstract

INTRODUCTION

Scalp psoriasis frequently goes with other disease location and may lead to a significant burden and impairment of quality of life (QoL). Adherence to local treatments is a frequent problem. A keratolytic and hydrating shampoo containing 2% salicylic acid, 5% urea, and 1% glycerin (active shampoo) has been developed for psoriasis-prone scalp.

OBJECTIVE

To assess the efficacy and tolerability of an active shampoo in subjects with mild to moderate scalp psoriasis.

MATERIALS AND METHODS

A single-center, randomized, double-blind, vehicle-controlled study was conducted on 67 adults with mild to moderate psoriasis. The active shampoo or its vehicle were applied daily for 14 days and 3 times/week for another 14 days. Assessments included the Psoriasis Scalp Severity Index (PSSI), Investigator Global Assessment (IGA), calculated total surface affected hair, scalp greasiness, irritation, and assessed scalp dermatitis-specific quality-of-life issues using SCALPDEX and product acceptability.

RESULTS

The active shampoo significantly (p < 0.05) reduced the PSSI by 39.0%, 37.2%, 63.0%, and 69.0% immediately after washing compared to a 22.8%, 5.5%, 19.6%, and 13.0% with the vehicle at Days 1, 8, 15, and 30, respectively. SCALPDEX items, IGA, and irritation significantly (p < 0.05) reduced with the active shampoo. Hair and scalp greasiness improved continuously with both products until Day 21. Subject-reported symptom scores paralleled the positive evolution of clinical signs. The active shampoo was well tolerated, subjects were highly satisfied and had an improved QoL.

CONCLUSION

The active shampoo significantly improved clinical signs, symptoms, and QoL of mild-to-moderate scalp psoriasis compared to the vehicle. It was very well tolerated and highly appreciated by the subjects.

Links

Publisher Full Text (DOI)

Authors+Show Affiliations

Massiot P
L'Oréal Research and Innovation, Clichy, France.
Pinto PC
PhDTrials, Lisbon, Portugal.
Leclerc-Mercier S
Laboratoires Vichy International, Levallois-Perret, France.
Rasmont V
Laboratoires Vichy International, Levallois-Perret, France.
Piraccini BM
Division of Dermatology, Department of Specialized, Diagnostic, and Experimental Medicine, University of Bologna, Bologna, Italy.
Rudnicka L
Department of Dermatology, Medical University of Warsaw, Warsaw, Poland.
Reygagne P
Sabouraud Centre, St Louis Hospital, Paris, France.
Melo DF
Department of Dermatology, University of State of Rio de Janeiro (UERJ), Rio de Janeiro, Brazil.
Vano-Galvan S
Ramon y Cajal University Hospital, TricoHRC, IRYCIS, University of Alcala, Madrid, Spain.
Wu WY
Department of Dermatology, Huashan Hospital Fudan University, Shanghai, China.
Kerob D
Cosmetic Active International, Levallois-Perret, France.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

36942745

Citation

Massiot, Philippe, et al. "Clinical Benefit and Tolerance Profile of a Keratolytic and Hydrating Shampoo in Subjects With Mild to Moderate Psoriasis. Results From a Double-blind, Randomized, Vehicle-controlled Study." Journal of Cosmetic Dermatology, 2023.
Massiot P, Pinto PC, Leclerc-Mercier S, et al. Clinical benefit and tolerance profile of a keratolytic and hydrating shampoo in subjects with mild to moderate psoriasis. Results from a double-blind, randomized, vehicle-controlled study. J Cosmet Dermatol. 2023.
Massiot, P., Pinto, P. C., Leclerc-Mercier, S., Rasmont, V., Piraccini, B. M., Rudnicka, L., Reygagne, P., Melo, D. F., Vano-Galvan, S., Wu, W. Y., & Kerob, D. (2023). Clinical benefit and tolerance profile of a keratolytic and hydrating shampoo in subjects with mild to moderate psoriasis. Results from a double-blind, randomized, vehicle-controlled study. Journal of Cosmetic Dermatology. https://doi.org/10.1111/jocd.15693
Massiot P, et al. Clinical Benefit and Tolerance Profile of a Keratolytic and Hydrating Shampoo in Subjects With Mild to Moderate Psoriasis. Results From a Double-blind, Randomized, Vehicle-controlled Study. J Cosmet Dermatol. 2023 Mar 21; PubMed PMID: 36942745.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical benefit and tolerance profile of a keratolytic and hydrating shampoo in subjects with mild to moderate psoriasis. Results from a double-blind, randomized, vehicle-controlled study. AU - Massiot,Philippe, AU - Pinto,Pedro Contreiras, AU - Leclerc-Mercier,Stephanie, AU - Rasmont,Virginie, AU - Piraccini,Bianca Maria, AU - Rudnicka,Lidia, AU - Reygagne,Pascal, AU - Melo,Daniel Fernandes, AU - Vano-Galvan,Sergio, AU - Wu,Wen-Yu, AU - Kerob,Delphine, Y1 - 2023/03/21/ PY - 2023/01/12/revised PY - 2022/10/31/received PY - 2023/02/14/accepted PY - 2023/3/21/entrez PY - 2023/3/22/pubmed PY - 2023/3/22/medline KW - dermocosmetic KW - psoriasis KW - randomized double-blind study KW - salicylic acid KW - scalp JF - Journal of cosmetic dermatology JO - J Cosmet Dermatol N2 - INTRODUCTION: Scalp psoriasis frequently goes with other disease location and may lead to a significant burden and impairment of quality of life (QoL). Adherence to local treatments is a frequent problem. A keratolytic and hydrating shampoo containing 2% salicylic acid, 5% urea, and 1% glycerin (active shampoo) has been developed for psoriasis-prone scalp. OBJECTIVE: To assess the efficacy and tolerability of an active shampoo in subjects with mild to moderate scalp psoriasis. MATERIALS AND METHODS: A single-center, randomized, double-blind, vehicle-controlled study was conducted on 67 adults with mild to moderate psoriasis. The active shampoo or its vehicle were applied daily for 14 days and 3 times/week for another 14 days. Assessments included the Psoriasis Scalp Severity Index (PSSI), Investigator Global Assessment (IGA), calculated total surface affected hair, scalp greasiness, irritation, and assessed scalp dermatitis-specific quality-of-life issues using SCALPDEX and product acceptability. RESULTS: The active shampoo significantly (p < 0.05) reduced the PSSI by 39.0%, 37.2%, 63.0%, and 69.0% immediately after washing compared to a 22.8%, 5.5%, 19.6%, and 13.0% with the vehicle at Days 1, 8, 15, and 30, respectively. SCALPDEX items, IGA, and irritation significantly (p < 0.05) reduced with the active shampoo. Hair and scalp greasiness improved continuously with both products until Day 21. Subject-reported symptom scores paralleled the positive evolution of clinical signs. The active shampoo was well tolerated, subjects were highly satisfied and had an improved QoL. CONCLUSION: The active shampoo significantly improved clinical signs, symptoms, and QoL of mild-to-moderate scalp psoriasis compared to the vehicle. It was very well tolerated and highly appreciated by the subjects. SN - 1473-2165 UR - https://www.unboundmedicine.com/medline/citation/36942745/Clinical_benefit_and_tolerance_profile_of_a_keratolytic_and_hydrating_shampoo_in_subjects_with_mild_to_moderate_psoriasis__Results_from_a_double_blind_randomized_vehicle_controlled_study_ DB - PRIME DP - Unbound Medicine ER -

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