Treatment of dark, hyperpigmented patches on human ski

Not Applicable

Completed

• Conditions: Mild to moderate hyperpigmentation due to melasma on both sides of the face, but otherwise healthy skin; Skin and Connective Tissue Diseases; Chloasma

• Registration Number: ISRCTN97532324
• Lead Sponsor: Beiersdorf AG

Brief Summary

2019 Results article in https://doi.org/10.1016/j.jid.2019.02.013 (added 02/03/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-09-29
• Study Start: 2018-06-12
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Women 18 to 65 years of age having general good health
2. Fitzpatrick skin type II-IV
3. Individuals with mild to moderate hyperpigmentation due to melasma on both sides of the face (score of 3-6 on according to the modified Griffiths’ scale1, where 0 = none and 9 = severe, halfpoints are acceptable to qualify)
4. Ability to understand the study concept (intellectual capacity and language skills) and to comply with the test schedule and study rules
5. Participant is willing and able to give written informed consent

Exclusion Criteria

1. Individuals who had laser resurfacing procedure, deep skin peel, Botox or injection with a dermal filler, or cosmetic procedures on the face within 6 months prior to enrollment
2. Individuals who had used depigmenting products within 2 months prior to enrollment
3. Individuals who have used any topical medications on the face for hyper pigmented lesions or other conditions, or use of photosensitizing medication or procedures (including corticosteroids, hydroquinone, alpha-hydroxy, beta-hydroxy or kojic acid, retinoic acid, retinol, salicylic acid, Vitamin C and Vitamin D preparations or derivatives thereof), bleaching products on the face, UV light therapy, topical prescription treatments, topical tretinoin on the face less than 30 days prior to the study entry
4. Individuals who have used Acitretin, isotretinoin, systemic retinoids (e.g. Accutane), methotrexate, or photoallergic, phototoxic or photo-sensitizing drugs within 6 months of baseline (and will refrain from use during the study)
5. Individuals who have had prior facial microdermabrasion (light or medium skin peel) treatment within 6 weeks prior to study entry.
6. Individuals diagnosed with known allergies to facial skin care products
7. Individuals who are nursing, pregnant, or planning to become pregnant during the study according to subject self-report including those who are not using an acceptable method of contraception throughout the study
8. Individuals with a history of skin cancer
9. Individuals having a health condition and/or pre-existing or dormant dermatologic disease on the face (e.g., psoriasis, rosacea, acne, eczema, seborrheic dermatitis, severe excoriations etc.) that the Investigator or designee deems inappropriate for participation or could interfere with the outcome of the study
10. Individuals with a history of immunosuppression/immune deficiency disorders (including (HIV infection or AIDS) or currently using immunosuppressive medications (e.g., zathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.) and/or radiation as determined by study documentation
11. Individuals with an uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism, or hypothyroidism. Individuals having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medication, etc

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical grading of overall hyperpigmentation (mottled and discrete) and discrete hyperpigmentation (MASI assessment) at baseline, week 4, week 8, and week 12

Secondary Outcome Measures

Name	Time	Method
Tolerability assessed using a self-assessment questionnaire at baseline, week 4, week 8, and week 12