solar lentigo
Conditions
Interventions
Twice a day (morning and evening). After face washing, apply the DRxHQ Brightning to the whole face, apply the retinoic acid preparation to pigmented area, and, apply the R610 to the same pigmented a
Retinoic acid preparation for 4 weeks, DRxHQ Brightning and R610 for 8 weeks.
Twice a day (morning and evening). After face washing, apply the DRxHQ Brightning to the whole face, apply the retinoic
Retinoic acid preparation for 4 weeks, DRxHQ Brightning and vehicle for 8 weeks.
Sponsors
Rohto Pharmaceutical Co., LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who have more than 2 counts of solar lentigo (each is over 5 mm in diameter) on the face, which are separated more than 1 cm from each other. 2. Subjects who understood the requirements of the study and signed the informed consent forms.
Exclusion criteria
Exclusion criteria: 1. Subjects with rash, contact dermatitis, skin inflammation e.g. sunburn, and other skin abnormality. 2. Subjects with the following treatment history at baseline. 2.1 Treatment region 1)Topical preparations i)Within the past 12 weeks -Retinoic acid, adapalene ii)Within the past 2 weeks -Anti-inflammatory drugs (corticosteroid, nonsteroidal anti-inflammatory drug) 2)Other therapy i)Within the past 4 weeks -Chemical peelings, laser treatment, photo-therapy, plastic surgery treatment. 2.2 Systemic drugs, supplements i)Within the past 12 weeks -Retinoic acid ii)Within the past 4 weeks -Corticosteroid 3. Subjects with skin viral infection e.g. flat wart, herpes simplex. 4. Subjects who changed face cleanser or skin care products for the test regions within the past 2 weeks. 5. Subjects who exposed to the ultraviolet rays of the sun. 6. Subjects with systemic diseases, e.g. severe heart disease, renal disease, hepatic disease, respiratory disease, cardiovascular disease, and immune disease. 7. Subjects with atopic dermatitis or have a history of atopic dermatitis. 8. Subjects who had experience the contact dermatitis caused by the use of hydroquinone. 9. Females who are pregnant, trying to become pregnant (self-declared), during this study period, or breast feeding. 10. Participants of another clinical study within 4 months of study initiation. 11. Subjects who are improper as a participant in this study in judgement by the principal or other investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degrees of dermatitis (erythema, edema, crust, drying, desquamation, feeling of stimulation, burning sensation, itching, irritation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy -Skin symptom score -Hemoglobin index -Subject impression Other -Melanin index -Degree of skin tone color scale | — |
Countries
Japan
Outcome results
None listed