A randomized, double-blind, placebo-controlled, comparative study: The safety and efficacy of 0.25% tetrahydrocurcumin (tumeric) cream as depigment agent against 4% hydroquinone cream

Household and Personal Care TODAY. 2010;44–46.
Agents that are used to ‘lighten’ or ‘whiten’ the skin are known as depigmenting agents/ whitening agents or skin tone lighteners. In cosmetics, such agents are found to be effective against localized hyperpigmentation, age spots and sun damage, and also help to impart a lighter skin tone. In medical practice, they are used in treating various pigmentation disorders.

Hydroquinone is one such agent that has been used as an active ingredient in skin tone lightening formulations for over 50 years. However, several adverse reactions, such as allergic and irritant contact dermatitis, leucoderma, and ochronosis, acneiform lesions and cancer (on prolonged use) have been reported that are associated with hydroquinone.

Hence, natural and safer alternatives like tetrahydrocurcumin are in great demand. This color-free compound is obtained from rhizomes of Curuma longa (turmeric). It is valued as a topical antioxidant and anti-inflammatory agent with potent free radical scavenging and lipid peroxidation inhibitory potential compared to vitamin E, kojic acid and vitamin C.


To validate the safety and efficacy of 0.25% tetrahydrocurcumin (SabiWhite®) against 4% hydroquinone as a depigmenting agent.

Study Design:

  • In this randomized, double-blind, placebo-controlled study 50 healthy individuals were enrolled
  • The study consisted of two phases: A patch test phase (phase 1) and a clinical trial phase (phase 2)
  • During phase 1, volunteers randomly applied either 0.25% tetrahydrocurcumin cream or water at the back (scapular area) and readings were taken after 48 h and 72 h
  • During phase 2, test products were randomly applied on the right forearm of each individual twice daily by the investigator using a standard template for 4 weeks
  • Mexameter readings were taken at baseline, week 1, 2, 3, and 4, whereas clinical photographs were taken at baseline and on week 4
  • Adverse reactions, if any, to the test products administered were monitored and recorded at week 1, 2 3 and 4

Results and Discussion:

  • No adverse reaction or irritation was experienced by any individual during phase 1 patch test
  • In phase 2 study, mean mexameter readings showed that 0.25% tetrahydrocurcumin cream produced a significant whitening effect compared to the negative control groups with no incidence of adverse reactions
  • However, time-dependent increase in incidence of adverse reactions was observed with 4% hydroquinone cream, with 50% of the subjects experiencing mild-to-moderate reactions towards the end of week 4


Hence, it was concluded that 0.25% tetrahydrocurcumin cream (SabiWhite®) is therefore a safe and effective alternative to 4% hydroquinone cream as a depigmenting agent.

Read More…