Anti-inflammatory activity of Physalis-based cream after laser application in the treatment of spots on the hands

Anti-inflammatory activity of the cream based on Physalis angulata L. extract after application of intense pulsed light in the treatment of solar melanosis of the hands

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

REBEC

Registry ID

RBR-49q54wg

Enrollment

Unknown

Registered

2021-02-12

Start date

2019-07-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solar melanosis

Interventions

Group G1: formed by 30 individuals of both sexes, healthy and aged 26 to 73 years, with phototype I to IV with a single application of intense pulsed light (IPL). The cream was applied with extract of

D06.472.040.585.353.476

B01.650.940.800.575.912.250.908.500.499

E02.774.465

Eligibility

Age

26 Years to 76 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers; both genders; ages between 26 and 76 years; non smokers; weight within the range of 15% of the weight considered normal for men and women taking into account height and physical structure; similar involvement by melanosis in both hands; negative dermoscopy for premalignant lesions; phototype between I to IV.

Exclusion criteria

Exclusion criteria: Volunteers with autoimmune diseases; hives; photosensitivity; previous history of skin cancer; pre-malignant lesions on the skin; signs of loss of skin barrier in the treated region; smokers.

Design outcomes

Primary

Measure	Time frame
Expected outcome 1: It was expected to find an anti-inflammatory effect of the cream containing 0.5% supercritical extract of Physalis angulata L. similar to the effect of 1% hydrocortisone.;Outcome found 1: In G1 there was no significant difference in hand temperature between the treatments studied (p = 0.261), use of cream containing 1% hydrocortisone and cream containing 0.5% P. angulata extract. In G2 in 28 participants (93.3%), the temperature was higher in the hand where the vehicle cream was applied in relation to the hand where the cream was used, the base of the extract of P. angulata 0.5%, this difference being above one degree Celsius, with significant difference (p = 0.000). Evidence of the anti-inflammatory effect of P. angulata. As for perilesional erythema in G2, it was greater in the right hand in 20 participants (66.6%), in individuals who received only the vehicle, when compared to those treated with the extract P. angulata 0.5%, it is worth mentioning that the difference was significant (p = 0.0001). In G1, it was lower in individuals treated with hydrocortisone 1% when compared to those treated with crema, the base of the extract P. angulata 0.5%, this being a significant difference (p = 0.001), showing the superiority of the anti-inflammatory effect of hydrocortisone to 1%.	—

Measure

Time frame

Expected outcome 1: It was expected to find an anti-inflammatory effect of the cream containing 0.5% supercritical extract of Physalis angulata L. similar to the effect of 1% hydrocortisone.;Outcome found 1: In G1 there was no significant difference in hand temperature between the treatments studied (p = 0.261), use of cream containing 1% hydrocortisone and cream containing 0.5% P. angulata extract. In G2 in 28 participants (93.3%), the temperature was higher in the hand where the vehicle cream was applied in relation to the hand where the cream was used, the base of the extract of P. angulata 0.5%, this difference being above one degree Celsius, with significant difference (p = 0.000). Evidence of the anti-inflammatory effect of P. angulata. As for perilesional erythema in G2, it was greater in the right hand in 20 participants (66.6%), in individuals who received only the vehicle, when compared to those treated with the extract P. angulata 0.5%, it is worth mentioning that the difference was significant (p = 0.0001). In G1, it was lower in individuals treated with hydrocortisone 1% when compared to those treated with crema, the base of the extract P. angulata 0.5%, this being a significant difference (p = 0.001), showing the superiority of the anti-inflammatory effect of hydrocortisone to 1%.

—

Countries

Brazil

Contacts

Public ContactRicardo Germano

Universidade Paranaense

prof.ricardogermano@gmail.com+55 (44)988038834

Outcome results

None listed

Source: REBEC (via WHO ICTRP)