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Two clinical studies done at Kilpauk medical college

Tolenorm oil Augments Repigmentation (study period 3 years)

  • Clinical study with 170 vitiligo patients was done to prove the efficacy of Tolenorm in enhancing re-pigmentation in vitiligenous skin.
  • The evaluation was done on the basis of repigmentation from the initial scale (before treatment).
  • Patients were asked to apply Tolenorm on the depigmented areas once a day after bath and have sun exposure for 5 minutes after application.
  • All the patients were reviewed every fortnight to record the percentage and the nature of repigmentation.

Study findings

  • 25% repigmentation within 12 weeks of treatment was observed
  • 90% repigmentation was observed in 3 years
  • The skin that got repigmented was found to be uniform, smooth and complete.

Duration Extent of repigmentation % of patients
12 weeks 25% 42%
1 year 50% 60%
2 years 75% 71%
3 years 90% 62%

Percentage of re pigmentation proves the efficacy of Tolenorm in the management of vitiligo

90% Re-pigmentation within 15 months with the use of Tolenorm (Study period 15 months)

60 patients with various types of Vitiligo were treated with both Tolenorm oil and Tolenorm ointment for a period of 15 months.

Patients were reviewed every fortnight and they were also clinically assessed for any untoward side effects as the drugs were used for a long time.

It was clinically proved that both Tolenorm oil and Tolenorm ointment were non toxic and safe for long term use.

Study findings

  • Repigmentation was observed in 8 weeks in all the cases.
  • 90% repigmentation was observed in 57% patients at the completion of study period
  • 11% showed complete repigmentation at the completion of the study period.

Time in Months Percentage of Repigmentation
6 Months 50%
12 Months 75%
15 Months 90%

Nearly complete repigmentation is possible with topical Tolenorm

Significant Increase in Tyrosinase Activity with Topical Tolenorm

  • Activation of tyrosinase enzyme (required for melanin formation in the skin) by application of topical Tolenorm was observed in this study.
  • Tyrosinase enzyme converts L-DOPA into DOPA chrome and then to melanin.
  • L-DOPA was treated with the enzyme in 1 st set of experiment.
  • In the second set of experiment, L-DOPA was treated with Tolenorm plus the enzyme.
  • The amount of DOPA chrome production is directly proportional to tyrosinase activity.

Study findings

  • Enzyme activity found to be significantly increased in Tolenorm treated cells with respect to control.

Effect of Tolenorm on tyrosinase activity in melanocytes-B16F10 cell line

Time in minutes Enzyme activity (IU/ml)
Control Tolenorm treated
1 10 10
2 90 180
3 92 200
4 88 300

The study reveals the effectiveness of Tolenorm oil on the tyrosinase enzyme activity.