A Randomized, Investigator-Blinded Comparison of Two Topical Regimens in Fitzpatrick Skin Types III-VI With Moderate to Severe Facial Hyperpigmentation

J Drugs Dermatol. 2017 Nov 1;16(11):1127-1132.


<p>Purpose: Though hydroquinone (HQ) remains the gold standard for treatment of hyperpigmentation, concerns about its safety have prompted the development of HQ-free topical skin lightening systems.

Objective: To compare the efficacy and tolerability of a new HQ-free system and a popular HQ-based system for the improvement of facial hyperpigmentation and photoaging in darker skin types.

Methods: This investigator-blinded trial randomized 30 subjects of Fitzpatrick skin types III to VI with moderate to severe hyperpigmentation to a new 7-product HQ-free system or a 7-product HQ-based system for 12 weeks. At 4, 8, and 12 week follow-up visits, a blinded investigator assessed efficacy and tolerability using standardized scales. Subjects also performed a self-assessment at each visit.

Summary: Both the HQ-free and HQ-based systems produced significant improvements in Overall Hyperpigmentation that were sustained through week 12 (P=0.008, 0.0003). The HQ-based system demonstrated better improvement in overall hyperpigmentation at weeks 4, 8, 12 (P=0.01, 0.001, 0.003, respectively). Mottled Pigmentation Area Severity Index (MoPASI) scores improved with both systems (P=0.02, 0.01), with no statistically significant differences between the two treatment groups. Subject-rated hyperpigmentation was not different between groups. Subjects reported significantly more discomfort with the HQ-free system at week 8 (P=0.02); otherwise, measures of irritation were the same between groups. All irritation was described as mild to moderate. At week 12, 100% of subjects in the HQ-free group and 92.3% of subjects in the HQ-based group were satisfied with their outcome.

Conclusion: Both a new HQ-free skincare system and a widely-available HQ-based system improved hyperpigmentation in Fitzpatrick skin types III to VI. Though the HQ-based system produced greater improvement in hyperpigmentation when compared to the HQ-free system, there was no difference in MoPASI scores between the treatment groups. Subjects were satisfied with both treatments and reported only mild to moderate irritation using either system.</p> <p><em>J Drugs Dermatol. 2017;16(11):1127-1132.</em></p>.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Cutaneous
  • Adult
  • Aged
  • Dermatologic Agents / administration & dosage
  • Dermatologic Agents / therapeutic use*
  • Facial Dermatoses / drug therapy*
  • Facial Dermatoses / pathology
  • Female
  • Humans
  • Hydroquinones / administration & dosage
  • Hydroquinones / therapeutic use*
  • Hyperpigmentation / drug therapy*
  • Hyperpigmentation / pathology
  • Male
  • Middle Aged
  • Severity of Illness Index
  • Single-Blind Method
  • Surveys and Questionnaires
  • Treatment Outcome


  • Dermatologic Agents
  • Hydroquinones
  • hydroquinone