Cysteamine Isobionic-Amide Complex Versus Kligman’s Formula for the Treatment of Melasma: Equal Efficacy and Rapid Onset of Action
February 2024 | Volume 23 | Issue 2 | 9 | Copyright © February 2024
Published online January 24, 2024
Mukta Sachdev MDa, Pearl E. Grimes MDb, Valerie Callender MDc, Corey L. Hartman MDd, Susan C. Taylor MDe, Nada Elbuluk MD MScf, Ashraf Badawi MDg, Yoko Funasaka MD PhDh, Joyce Lim MDi, Chau Yee Ng MDj, Seemal R. Desai MDk
aDepartment of Dermatology, Manipal Hospital, Bangalore, India
bDermatology University of California, Los Angeles, CA
cHoward University College of Medicine Medical Director, Callender Dermatology & Cosmetic Center, Founder & Principal Investigator, Callender Center for Clinical Research, Glen Dale, MD
dSkin Wellness Dermatology, Birmingham, AL
ePerelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
fUSC Department of Dermatology, Keck School of Medicine, CA
gLaser Institute, Cairo University, Egypt
hDepartment of Dermatology, Nippon Medical School, Tokyo, Japan
iJoyce Lim Skin and Laser Clinic, Singapore
jDepartment of Dermatology, Chang Gung Memorial Hospital, Taipei, Linkou, Taiwan Vitiligo Clinic, and Pigment Research Center, Chang Gung Memorial Hospital, Linkou, Taiwan Department of Dermatology and Aesthetic Medicine Center, Jen-Ai Hospital, Taichung, Taiwan
kDepartment of Dermatology, The University of Texas Southwestern Medical Center, and Innovative Dermatology, Dallas, TX
Abstract
Background: Modified Kligman's formula (mKF) is the gold standard treatment for melasma; however, its prolonged use is not recommended due to side effects. Cysteamine is a potent, safe, and effective depigmenting agent. Here, we conducted a double-blind, randomized, and placebo-controlled clinical trial to assess the efficacy of cysteamine isobionic-amide -- a complex with enhanced depigmenting efficacy -- and compared it to mKF for the treatment of melasma.
Methods: This study involved a total of 80 patients divided into 3 groups: cysteamine-isobionic amide, placebo, or mKF. The modified Melasma Area Severity Index (mMASI) score and spectrophotometric evaluation were conducted at baseline, week 4, week 8, and week 16. Dermatological assessment, patients’ feedback, and satisfaction including quality-of-life scores were also collected.
Results: At week 4, cysteamine isobionic-amide and mKF groups showed an equivalent onset of action in terms of mMASI and skin pigmentation contrast reduction. The 2 groups significantly reduced melasma severity and improved the overall skin condition with a comparable efficacy at week 16. Quality of life of melasma patients was significantly improved in the cysteamine isobionic-amide group at week 8 and further at week 16 (P<0.001) compared to the mKF group. Patients’ feedback and satisfaction were higher with the cysteamine isobionic-amide product compared to mKF.
Conclusion: Cysteamine isobionic-amide provided a rapid onset of action and was as effective as the mKF for the treatment of melasma. The data suggest that cysteamine isobionic-amide could potentially be an acceptable alternative to mKF for the long-term treatment of melasma.
J Drugs Dermatol. 2024;23(2):9-16. doi:10.36849/JDD.7428
INTRODUCTION
Melasma is an acquired, pigmentary disorder characterized by the appearance of light brown to dark macules on sun-exposed areas of the body, most commonly occurring on the face. It can affect all racial and ethnic groups but is more common in women and individuals of color.1 Melasma is known to significantly impact the psychological health and therefore the quality of life of the people affected.2,3
Over the years, a wide range of depigmenting compounds have been introduced for the treatment of melasma.4-7 Hydroquinone (HQ) is an effective depigmenting agent used for the treatment of epidermal melasma. Several mechanisms of action have been proposed for HQ over the years, such as tyrosinase inhibition, modification of melanosome formation, or reduction of DNA and RNA synthesis with concomitant melanosome degradation and melanocyte destruction.8-12
